2013
|
Journal Articles
|
| Gisela Henriques, Axel Martinelli, Louise Rodrigues, Katarzyna Modrzynska, Richard Fawcett, Douglas R Houston, Sofia T Borges, Umberto d’Alessandro, Halidou Tinto, Corine Karema, Paul Hunt, Pedro Cravo Artemisinin resistance in rodent malaria–mutation in the AP2
adaptor $mu$-chain suggests involvement of endocytosis and
membrane protein trafficking (Journal Article) In: Malar. J., vol. 12, no. 1, pp. 118, 2013. @article{Henriques2013-ee,
title = {Artemisinin resistance in rodent malaria--mutation in the AP2
adaptor $mu$-chain suggests involvement of endocytosis and
membrane protein trafficking},
author = {Gisela Henriques and Axel Martinelli and Louise Rodrigues and Katarzyna Modrzynska and Richard Fawcett and Douglas R Houston and Sofia T Borges and Umberto d'Alessandro and Halidou Tinto and Corine Karema and Paul Hunt and Pedro Cravo},
year = {2013},
date = {2013-04-01},
journal = {Malar. J.},
volume = {12},
number = {1},
pages = {118},
publisher = {Springer Nature},
abstract = {BACKGROUND: The control of malaria, caused by Plasmodium
falciparum, is hampered by the relentless evolution of drug
resistance. Because artemisinin derivatives are now used in the
most effective anti-malarial therapy, resistance to artemisinin
would be catastrophic. Indeed, studies suggest that artemisinin
resistance has already appeared in natural infections.
Understanding the mechanisms of resistance would help to prolong
the effective lifetime of these drugs. Genetic markers of
resistance are therefore required urgently. Previously, a
mutation in a de-ubiquitinating enzyme was shown to confer
artemisinin resistance in the rodent malaria parasite Plasmodium
chabaudi. METHODS: Here, for a mutant P. chabaudi malaria
parasite and its immediate progenitor, the in vivo artemisinin
resistance phenotypes and the mutations arising using Illumina
whole-genome re-sequencing were compared. RESULTS: An increased
artemisinin resistance phenotype is accompanied by one
non-synonymous substitution. The mutated gene encodes the
$mu$-chain of the AP2 adaptor complex, a component of the
endocytic machinery. Homology models indicate that the mutated
residue interacts with a cargo recognition sequence. In natural
infections of the human malaria parasite P. falciparum, 12
polymorphisms (nine SNPs and three indels) were identified in
the orthologous gene. CONCLUSION: An increased
artemisinin-resistant phenotype occurs along with a mutation in
a functional element of the AP2 adaptor protein complex. This
suggests that endocytosis and trafficking of membrane proteins
may be involved, generating new insights into possible
mechanisms of resistance. The genotypes of this adaptor protein
can be evaluated for its role in artemisinin responses in human
infections of P. falciparum.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND: The control of malaria, caused by Plasmodium
falciparum, is hampered by the relentless evolution of drug
resistance. Because artemisinin derivatives are now used in the
most effective anti-malarial therapy, resistance to artemisinin
would be catastrophic. Indeed, studies suggest that artemisinin
resistance has already appeared in natural infections.
Understanding the mechanisms of resistance would help to prolong
the effective lifetime of these drugs. Genetic markers of
resistance are therefore required urgently. Previously, a
mutation in a de-ubiquitinating enzyme was shown to confer
artemisinin resistance in the rodent malaria parasite Plasmodium
chabaudi. METHODS: Here, for a mutant P. chabaudi malaria
parasite and its immediate progenitor, the in vivo artemisinin
resistance phenotypes and the mutations arising using Illumina
whole-genome re-sequencing were compared. RESULTS: An increased
artemisinin resistance phenotype is accompanied by one
non-synonymous substitution. The mutated gene encodes the
$mu$-chain of the AP2 adaptor complex, a component of the
endocytic machinery. Homology models indicate that the mutated
residue interacts with a cargo recognition sequence. In natural
infections of the human malaria parasite P. falciparum, 12
polymorphisms (nine SNPs and three indels) were identified in
the orthologous gene. CONCLUSION: An increased
artemisinin-resistant phenotype occurs along with a mutation in
a functional element of the AP2 adaptor protein complex. This
suggests that endocytosis and trafficking of membrane proteins
may be involved, generating new insights into possible
mechanisms of resistance. The genotypes of this adaptor protein
can be evaluated for its role in artemisinin responses in human
infections of P. falciparum. |
| Halidou Tinto, Ramadhani A Noor, Charles L Wanga, Innocent Valea, Maimouna Ndour Mbaye, Umberto D’Alessandro, Raffaella M Ravinetto Good clinical practice in resource-limited settings: translating
theory into practice (Journal Article) In: Am. J. Trop. Med. Hyg., vol. 88, no. 4, pp. 608–613, 2013. @article{Tinto2013-rv,
title = {Good clinical practice in resource-limited settings: translating
theory into practice},
author = {Halidou Tinto and Ramadhani A Noor and Charles L Wanga and Innocent Valea and Maimouna Ndour Mbaye and Umberto D'Alessandro and Raffaella M Ravinetto},
year = {2013},
date = {2013-04-01},
journal = {Am. J. Trop. Med. Hyg.},
volume = {88},
number = {4},
pages = {608--613},
publisher = {American Society of Tropical Medicine and Hygiene},
abstract = {A Good Clinical Practices (GCPs) course, based on the
combination of theoretical modules with a practical training in
real-life conditions, was held in 2010 in Burkina Faso. It was
attended by 15 trainees from nine African, Asian, and Latin
American countries. There were some discrepancies between the
average good results at the end of the theoretical phase and the
GCP application during the first days of the practical phase,
underlying the difficulties of translating theoretical knowledge
into good practices. Most of the findings were not unexpected
and reflected the challenges commonly faced by clinical
investigators in resource-poor contexts (i.e., the high workload
at peripheral health facilities, the need to conciliate routine
clinical activities with clinical research, and the risk of
creating a double standard among patients attending the same
health facility [free care for recruited patients versus user
fees for non-recruited patients with the same medical
condition]). Even if limited in number and time, these
observations suggest that a theoretical training alone may not
be sufficient to prepare trainees for the challenges of medical
research in real-life settings. Conversely, when a practical
phase immediately follows a theoretical one, trainees can
immediately experience what the research methodology implicates
in terms of work organization and relationship with recruited
and non-recruited patients. This initial experience shows the
complexity of translating GCP into practice and suggests the
need to rethink the current conception of GCP training.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
A Good Clinical Practices (GCPs) course, based on the
combination of theoretical modules with a practical training in
real-life conditions, was held in 2010 in Burkina Faso. It was
attended by 15 trainees from nine African, Asian, and Latin
American countries. There were some discrepancies between the
average good results at the end of the theoretical phase and the
GCP application during the first days of the practical phase,
underlying the difficulties of translating theoretical knowledge
into good practices. Most of the findings were not unexpected
and reflected the challenges commonly faced by clinical
investigators in resource-poor contexts (i.e., the high workload
at peripheral health facilities, the need to conciliate routine
clinical activities with clinical research, and the risk of
creating a double standard among patients attending the same
health facility [free care for recruited patients versus user
fees for non-recruited patients with the same medical
condition]). Even if limited in number and time, these
observations suggest that a theoretical training alone may not
be sufficient to prepare trainees for the challenges of medical
research in real-life settings. Conversely, when a practical
phase immediately follows a theoretical one, trainees can
immediately experience what the research methodology implicates
in terms of work organization and relationship with recruited
and non-recruited patients. This initial experience shows the
complexity of translating GCP into practice and suggests the
need to rethink the current conception of GCP training. |
| Sanata Bamba, Adama Séré, Rodrigues Nikiéma, Tinto Halidou, Blandine Thiéba, Blami Dao, Robert Tinga Guiguemdé Traitement préventif intermittent `a la sulfadoxine —
pyriméthamine du paludisme chez les femmes enceintes:
efficacité et observance dans deux h^opitaux urbains du
Burkina Faso (Journal Article) In: Pan Afr. Med. J., vol. 14, pp. 105, 2013. @article{Bamba2013-ua,
title = {Traitement pr\'{e}ventif intermittent `a la sulfadoxine --
pyrim\'{e}thamine du paludisme chez les femmes enceintes:
efficacit\'{e} et observance dans deux h^opitaux urbains du
Burkina Faso},
author = {Sanata Bamba and Adama S\'{e}r\'{e} and Rodrigues Niki\'{e}ma and Tinto Halidou and Blandine Thi\'{e}ba and Blami Dao and Robert Tinga Guiguemd\'{e}},
year = {2013},
date = {2013-03-01},
journal = {Pan Afr. Med. J.},
volume = {14},
pages = {105},
publisher = {Pan African Medical Journal},
keywords = {Burkina Faso; Grossesse; Intermittent Preventive Treatment; Malaria; effectiveness; observance; pyrimethamine; sulfadoxine; woman},
pubstate = {published},
tppubtype = {article}
}
|
| Zeno Bisoffi, Halidou Tinto, Bienvenu Sodiomon Sirima, Federico Gobbi, Andrea Angheben, Dora Buonfrate, Jef Van den Ende Should malaria treatment be guided by a point of care rapid
test? A threshold approach to malaria management in rural
Burkina Faso (Journal Article) In: PLoS One, vol. 8, no. 3, pp. e58019, 2013. @article{Bisoffi2013-bz,
title = {Should malaria treatment be guided by a point of care rapid
test? A threshold approach to malaria management in rural
Burkina Faso},
author = {Zeno Bisoffi and Halidou Tinto and Bienvenu Sodiomon Sirima and Federico Gobbi and Andrea Angheben and Dora Buonfrate and Jef Van den Ende},
year = {2013},
date = {2013-03-01},
journal = {PLoS One},
volume = {8},
number = {3},
pages = {e58019},
publisher = {Public Library of Science (PLoS)},
abstract = {BACKGROUND: In Burkina Faso, rapid diagnostic tests for malaria
have been made recently available. Previously, malaria was
managed clinically. This study aims at assessing which is the
best management option of a febrile patient in a hyperendemic
setting. Three alternatives are: treating presumptively,
testing, or refraining from both test and treatment. The test
threshold is the tradeoff between refraining and testing, the
test-treatment threshold is the tradeoff between testing and
treating. Only if the disease probability lies between the two
should the test be used. METHODS AND FINDINGS: Data for this
analysis was obtained from previous studies on malaria rapid
tests, involving 5220 patients. The thresholds were calculated,
based on disease risk, treatment risk and cost, test accuracy
and cost. The thresholds were then matched against the disease
probability. For a febrile child under 5 in the dry season, the
pre-test probability of clinical malaria (3.2%), was just above
the test/treatment threshold. In the rainy season, that
probability was 63%, largely above the test/treatment
threshold. For febrile children >5 years and adults in the dry
season, the probability was 1.7%, below the test threshold,
while in the rainy season it was higher (25.1%), and situated
between the two thresholds (3% and 60.9%), only if costs were
not considered. If they were, neither testing nor treating with
artemisinin combination treatments (ACT) would be recommended.
CONCLUSIONS: A febrile child under 5 should be treated
presumptively. In the dry season, the probability of clinical
malaria in adults is so low, that neither testing nor treating
with any regimen should be recommended. In the rainy season, if
costs are considered, a febrile adult should not be tested, nor
treated with ACT, but a possible alternative would be a
presumptive treatment with amodiaquine plus
sulfadoxine-pyrimethamine. If costs were not considered, testing
would be recommended.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND: In Burkina Faso, rapid diagnostic tests for malaria
have been made recently available. Previously, malaria was
managed clinically. This study aims at assessing which is the
best management option of a febrile patient in a hyperendemic
setting. Three alternatives are: treating presumptively,
testing, or refraining from both test and treatment. The test
threshold is the tradeoff between refraining and testing, the
test-treatment threshold is the tradeoff between testing and
treating. Only if the disease probability lies between the two
should the test be used. METHODS AND FINDINGS: Data for this
analysis was obtained from previous studies on malaria rapid
tests, involving 5220 patients. The thresholds were calculated,
based on disease risk, treatment risk and cost, test accuracy
and cost. The thresholds were then matched against the disease
probability. For a febrile child under 5 in the dry season, the
pre-test probability of clinical malaria (3.2%), was just above
the test/treatment threshold. In the rainy season, that
probability was 63%, largely above the test/treatment
threshold. For febrile children >5 years and adults in the dry
season, the probability was 1.7%, below the test threshold,
while in the rainy season it was higher (25.1%), and situated
between the two thresholds (3% and 60.9%), only if costs were
not considered. If they were, neither testing nor treating with
artemisinin combination treatments (ACT) would be recommended.
CONCLUSIONS: A febrile child under 5 should be treated
presumptively. In the dry season, the probability of clinical
malaria in adults is so low, that neither testing nor treating
with any regimen should be recommended. In the rainy season, if
costs are considered, a febrile adult should not be tested, nor
treated with ACT, but a possible alternative would be a
presumptive treatment with amodiaquine plus
sulfadoxine-pyrimethamine. If costs were not considered, testing
would be recommended. |
| Raffaella M Ravinetto, Ambrose Talisuna, Maaike De Crop, Harry Loen, Joris Menten, Chantal Van Overmeir, Halidou Tinto, Raquel Gonzalez, Martin Meremikwu, Carolyn Nabasuma, Ghyslain M Ngoma, Corine Karema, Yeka Adoke, Mike Chaponda, Jean-Pierre Van Geertruyden, Umberto D’Alessandro Challenges of non-commercial multicentre North-South
collaborative clinical trials (Journal Article) In: Trop. Med. Int. Health, vol. 18, no. 2, pp. 237–241, 2013. @article{Ravinetto2013-hg,
title = {Challenges of non-commercial multicentre North-South
collaborative clinical trials},
author = {Raffaella M Ravinetto and Ambrose Talisuna and Maaike De Crop and Harry Loen and Joris Menten and Chantal Van Overmeir and Halidou Tinto and Raquel Gonzalez and Martin Meremikwu and Carolyn Nabasuma and Ghyslain M Ngoma and Corine Karema and Yeka Adoke and Mike Chaponda and Jean-Pierre Van Geertruyden and Umberto D'Alessandro},
year = {2013},
date = {2013-02-01},
journal = {Trop. Med. Int. Health},
volume = {18},
number = {2},
pages = {237--241},
publisher = {Wiley},
abstract = {The last decade has witnessed a substantial increase of
multi-centre, public health-oriented clinical trials in poor
countries. However, non-commercial research groups have less
staff and financial resources than traditional commercial
sponsors, so the trial teams have to be creative to comply with
Good Clinical Practices (GCP) requirements. According to the
recent experience of a large multicentre trial on antimalarials,
major challenges result from the complexity of multiple ethical
review, the costs of in-depth monitoring at several sites,
setting up an adequate Good Clinical Laboratory Practices (GCLP)
framework, lack of insurers in host countries, and lack of
adequate non-commercial data management software. Public
research funding agencies need to consider these challenges in
their funding policies. They also could support common spaces
where North-South collaborative research groups may share
critical information, such as on research insurance and
open-source, GCP-compliant software. WHO should update its GCP
guidelines, which date back to 1995, to incorporate the
perspectives and needs of non-commercial clinical research.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
The last decade has witnessed a substantial increase of
multi-centre, public health-oriented clinical trials in poor
countries. However, non-commercial research groups have less
staff and financial resources than traditional commercial
sponsors, so the trial teams have to be creative to comply with
Good Clinical Practices (GCP) requirements. According to the
recent experience of a large multicentre trial on antimalarials,
major challenges result from the complexity of multiple ethical
review, the costs of in-depth monitoring at several sites,
setting up an adequate Good Clinical Laboratory Practices (GCLP)
framework, lack of insurers in host countries, and lack of
adequate non-commercial data management software. Public
research funding agencies need to consider these challenges in
their funding policies. They also could support common spaces
where North-South collaborative research groups may share
critical information, such as on research insurance and
open-source, GCP-compliant software. WHO should update its GCP
guidelines, which date back to 1995, to incorporate the
perspectives and needs of non-commercial clinical research. |
| Yazoume Ye, Catherine Kyobutungi, Bernhards Ogutu, Leopoldo Villegas, Diadier Diallo, Halidou Tinto, Abraham Oduro, Osman Sankoh Malaria mortality estimates: need for agreeable approach (Journal Article) In: Trop. Med. Int. Health, vol. 18, no. 2, pp. 219–221, 2013. @article{Ye2013-vs,
title = {Malaria mortality estimates: need for agreeable approach},
author = {Yazoume Ye and Catherine Kyobutungi and Bernhards Ogutu and Leopoldo Villegas and Diadier Diallo and Halidou Tinto and Abraham Oduro and Osman Sankoh},
year = {2013},
date = {2013-02-01},
journal = {Trop. Med. Int. Health},
volume = {18},
number = {2},
pages = {219--221},
publisher = {Wiley},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
|
2012
|
Journal Articles
|
| S Clinical Trials Partnership RTS, Selidji Todagbe Agnandji, Bertrand Lell, José Francisco Fernandes, Béatrice Peggy Abossolo, Barbara Gaelle Nfono Ondo Methogo, Anita Lumeka Kabwende, Ayola Akim Adegnika, Benjamin Mordmüller, Saadou Issifou, Peter Gottfried Kremsner, Jahit Sacarlal, Pedro Aide, Miguel Lanaspa, John J Aponte, Sonia Machevo, Sozinho Acacio, Helder Bulo, Betuel Sigauque, Eusébio Macete, Pedro Alonso, Salim Abdulla, Nahya Salim, Rose Minja, Maxmillian Mpina, Saumu Ahmed, Ali Mohammed Ali, Ali Takadir Mtoro, Ali Said Hamad, Paul Mutani, Marcel Tanner, Halidou Tinto, Umberto D’Alessandro, Hermann Sorgho, Innocent Valea, Biébo Bihoun, Issa Guiraud, Berenger Kaboré, Olivier Sombié, Robert Tinga Guiguemdé, Jean Bosco Ouédraogo, Mary J Hamel, Simon Kariuki, Martina Oneko, Chris Odero, Kephas Otieno, Norbert Awino, Meredith McMorrow, Vincent Muturi-Kioi, Kayla F Laserson, Laurence Slutsker, Walter Otieno, Lucas Otieno, Nekoye Otsyula, Stacey Gondi, Allan Otieno, Victorine Owira, Esther Oguk, George Odongo, Jon Ben Woods, Bernhards Ogutu, Patricia Njuguna, Roma Chilengi, Pauline Akoo, Christine Kerubo, Charity Maingi, Trudie Lang, Ally Olotu, Philip Bejon, Kevin Marsh, Gabriel Mwambingu, Seth Owusu-Agyei, Kwaku Poku Asante, Kingsley Osei-Kwakye, Owusu Boahen, David Dosoo, Isaac Asante, George Adjei, Evans Kwara, Daniel Chandramohan, Brian Greenwood, John Lusingu, Samwel Gesase, Anangisye Malabeja, Omari Abdul, Coline Mahende, Edwin Liheluka, Lincoln Malle, Martha Lemnge, Thor G Theander, Chris Drakeley, Daniel Ansong, Tsiri Agbenyega, Samuel Adjei, Harry Owusu Boateng, Theresa Rettig, John Bawa, Justice Sylverken, David Sambian, Anima Sarfo, Alex Agyekum, Francis Martinson, Irving Hoffman, Tisungane Mvalo, Portia Kamthunzi, Rutendo Nkomo, Tapiwa Tembo, Gerald Tegha, Mercy Tsidya, Jane Kilembe, Chimwemwe Chawinga, W Ripley Ballou, Joe Cohen, Yolanda Guerra, Erik Jongert, Didier Lapierre, Amanda Leach, Marc Lievens, Opokua Ofori-Anyinam, Aurélie Olivier, Johan Vekemans, Terrell Carter, David Kaslow, Didier Leboulleux, Christian Loucq, Afiya Radford, Barbara Savarese, David Schellenberg, Marla Sillman, Preeti Vansadia A phase 3 trial of RTS,S/AS01 malaria vaccine in African
infants (Journal Article) In: N. Engl. J. Med., vol. 367, no. 24, pp. 2284–2295, 2012. @article{RTSS_Clinical_Trials_Partnership2012-am,
title = {A phase 3 trial of RTS,S/AS01 malaria vaccine in African
infants},
author = {S Clinical Trials Partnership RTS and Selidji Todagbe Agnandji and Bertrand Lell and Jos\'{e} Francisco Fernandes and B\'{e}atrice Peggy Abossolo and Barbara Gaelle Nfono Ondo Methogo and Anita Lumeka Kabwende and Ayola Akim Adegnika and Benjamin Mordm\"{u}ller and Saadou Issifou and Peter Gottfried Kremsner and Jahit Sacarlal and Pedro Aide and Miguel Lanaspa and John J Aponte and Sonia Machevo and Sozinho Acacio and Helder Bulo and Betuel Sigauque and Eus\'{e}bio Macete and Pedro Alonso and Salim Abdulla and Nahya Salim and Rose Minja and Maxmillian Mpina and Saumu Ahmed and Ali Mohammed Ali and Ali Takadir Mtoro and Ali Said Hamad and Paul Mutani and Marcel Tanner and Halidou Tinto and Umberto D'Alessandro and Hermann Sorgho and Innocent Valea and Bi\'{e}bo Bihoun and Issa Guiraud and Berenger Kabor\'{e} and Olivier Sombi\'{e} and Robert Tinga Guiguemd\'{e} and Jean Bosco Ou\'{e}draogo and Mary J Hamel and Simon Kariuki and Martina Oneko and Chris Odero and Kephas Otieno and Norbert Awino and Meredith McMorrow and Vincent Muturi-Kioi and Kayla F Laserson and Laurence Slutsker and Walter Otieno and Lucas Otieno and Nekoye Otsyula and Stacey Gondi and Allan Otieno and Victorine Owira and Esther Oguk and George Odongo and Jon Ben Woods and Bernhards Ogutu and Patricia Njuguna and Roma Chilengi and Pauline Akoo and Christine Kerubo and Charity Maingi and Trudie Lang and Ally Olotu and Philip Bejon and Kevin Marsh and Gabriel Mwambingu and Seth Owusu-Agyei and Kwaku Poku Asante and Kingsley Osei-Kwakye and Owusu Boahen and David Dosoo and Isaac Asante and George Adjei and Evans Kwara and Daniel Chandramohan and Brian Greenwood and John Lusingu and Samwel Gesase and Anangisye Malabeja and Omari Abdul and Coline Mahende and Edwin Liheluka and Lincoln Malle and Martha Lemnge and Thor G Theander and Chris Drakeley and Daniel Ansong and Tsiri Agbenyega and Samuel Adjei and Harry Owusu Boateng and Theresa Rettig and John Bawa and Justice Sylverken and David Sambian and Anima Sarfo and Alex Agyekum and Francis Martinson and Irving Hoffman and Tisungane Mvalo and Portia Kamthunzi and Rutendo Nkomo and Tapiwa Tembo and Gerald Tegha and Mercy Tsidya and Jane Kilembe and Chimwemwe Chawinga and W Ripley Ballou and Joe Cohen and Yolanda Guerra and Erik Jongert and Didier Lapierre and Amanda Leach and Marc Lievens and Opokua Ofori-Anyinam and Aur\'{e}lie Olivier and Johan Vekemans and Terrell Carter and David Kaslow and Didier Leboulleux and Christian Loucq and Afiya Radford and Barbara Savarese and David Schellenberg and Marla Sillman and Preeti Vansadia},
year = {2012},
date = {2012-12-01},
journal = {N. Engl. J. Med.},
volume = {367},
number = {24},
pages = {2284--2295},
abstract = {BACKGROUND: The candidate malaria vaccine RTS,S/AS01 reduced
episodes of both clinical and severe malaria in children 5 to 17
months of age by approximately 50% in an ongoing phase 3 trial.
We studied infants 6 to 12 weeks of age recruited for the same
trial. METHODS: We administered RTS,S/AS01 or a comparator
vaccine to 6537 infants who were 6 to 12 weeks of age at the time
of the first vaccination in conjunction with Expanded Program on
Immunization (EPI) vaccines in a three-dose monthly schedule.
Vaccine efficacy against the first or only episode of clinical
malaria during the 12 months after vaccination, a coprimary end
point, was analyzed with the use of Cox regression. Vaccine
efficacy against all malaria episodes, vaccine efficacy against
severe malaria, safety, and immunogenicity were also assessed.
RESULTS: The incidence of the first or only episode of clinical
malaria in the intention-to-treat population during the 14 months
after the first dose of vaccine was 0.31 per person-year in the
RTS,S/AS01 group and 0.40 per person-year in the control group,
for a vaccine efficacy of 30.1% (95% confidence interval [CI],
23.6 to 36.1). Vaccine efficacy in the per-protocol population
was 31.3% (97.5% CI, 23.6 to 38.3). Vaccine efficacy against
severe malaria was 26.0% (95% CI, -7.4 to 48.6) in the
intention-to-treat population and 36.6% (95% CI, 4.6 to 57.7)
in the per-protocol population. Serious adverse events occurred
with a similar frequency in the two study groups. One month after
administration of the third dose of RTS,S/AS01, 99.7% of
children were positive for anti-circumsporozoite antibodies, with
a geometric mean titer of 209 EU per milliliter (95% CI, 197 to
222). CONCLUSIONS: The RTS,S/AS01 vaccine coadministered with EPI
vaccines provided modest protection against both clinical and
severe malaria in young infants. (Funded by GlaxoSmithKline
Biologicals and the PATH Malaria Vaccine Initiative; RTS,S
ClinicalTrials.gov number, NCT00866619.).},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND: The candidate malaria vaccine RTS,S/AS01 reduced
episodes of both clinical and severe malaria in children 5 to 17
months of age by approximately 50% in an ongoing phase 3 trial.
We studied infants 6 to 12 weeks of age recruited for the same
trial. METHODS: We administered RTS,S/AS01 or a comparator
vaccine to 6537 infants who were 6 to 12 weeks of age at the time
of the first vaccination in conjunction with Expanded Program on
Immunization (EPI) vaccines in a three-dose monthly schedule.
Vaccine efficacy against the first or only episode of clinical
malaria during the 12 months after vaccination, a coprimary end
point, was analyzed with the use of Cox regression. Vaccine
efficacy against all malaria episodes, vaccine efficacy against
severe malaria, safety, and immunogenicity were also assessed.
RESULTS: The incidence of the first or only episode of clinical
malaria in the intention-to-treat population during the 14 months
after the first dose of vaccine was 0.31 per person-year in the
RTS,S/AS01 group and 0.40 per person-year in the control group,
for a vaccine efficacy of 30.1% (95% confidence interval [CI],
23.6 to 36.1). Vaccine efficacy in the per-protocol population
was 31.3% (97.5% CI, 23.6 to 38.3). Vaccine efficacy against
severe malaria was 26.0% (95% CI, -7.4 to 48.6) in the
intention-to-treat population and 36.6% (95% CI, 4.6 to 57.7)
in the per-protocol population. Serious adverse events occurred
with a similar frequency in the two study groups. One month after
administration of the third dose of RTS,S/AS01, 99.7% of
children were positive for anti-circumsporozoite antibodies, with
a geometric mean titer of 209 EU per milliliter (95% CI, 197 to
222). CONCLUSIONS: The RTS,S/AS01 vaccine coadministered with EPI
vaccines provided modest protection against both clinical and
severe malaria in young infants. (Funded by GlaxoSmithKline
Biologicals and the PATH Malaria Vaccine Initiative; RTS,S
ClinicalTrials.gov number, NCT00866619.). |
| Karim Derra, Eli Rouamba, Adama Kazienga, Sayouba Ouedraogo, Marc C Tahita, Hermann Sorgho, Innocent Valea, Halidou Tinto Profile: Nanoro Health and Demographic Surveillance System (Journal Article) In: Int. J. Epidemiol., vol. 41, no. 5, pp. 1293–1301, 2012. @article{Derra2012-bz,
title = {Profile: Nanoro Health and Demographic Surveillance System},
author = {Karim Derra and Eli Rouamba and Adama Kazienga and Sayouba Ouedraogo and Marc C Tahita and Hermann Sorgho and Innocent Valea and Halidou Tinto},
year = {2012},
date = {2012-10-01},
journal = {Int. J. Epidemiol.},
volume = {41},
number = {5},
pages = {1293--1301},
publisher = {Oxford University Press (OUP)},
abstract = {The Nanoro Health and Demographic Surveillance System (HDSS),
located in the rural centre of Burkina Faso, was established in
2009 by the Clinical Research Unit of Nanoro with the aim of
providing a core framework for clinical trials and also to
support the Burkina Faso health authorities in generating
epidemiological data that can contribute to the setup and
assessment of health interventions. In the baseline of initial
census, 54 781 individuals were recorded of whom 56.1% are
female. After the initial census, vital events such as
pregnancies, births, migrations and deaths have been monitored,
and data on individuals and household characteristics are
updated during regular 4-monthly household visits. The available
data are categorized into demographic, cultural, socio-economic
and health information, and are used for monitoring and
evaluation of population development issues. As a young site,
our objective has been to strengthen our skills and knowledge
and share new scientific experiences with INDEPTH and HDSS sites
in Burkina Faso. In addition, all data produced by the Nanoro
HDSS will be made publicly available through the INDEPTH data
sharing system.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
The Nanoro Health and Demographic Surveillance System (HDSS),
located in the rural centre of Burkina Faso, was established in
2009 by the Clinical Research Unit of Nanoro with the aim of
providing a core framework for clinical trials and also to
support the Burkina Faso health authorities in generating
epidemiological data that can contribute to the setup and
assessment of health interventions. In the baseline of initial
census, 54 781 individuals were recorded of whom 56.1% are
female. After the initial census, vital events such as
pregnancies, births, migrations and deaths have been monitored,
and data on individuals and household characteristics are
updated during regular 4-monthly household visits. The available
data are categorized into demographic, cultural, socio-economic
and health information, and are used for monitoring and
evaluation of population development issues. As a young site,
our objective has been to strengthen our skills and knowledge
and share new scientific experiences with INDEPTH and HDSS sites
in Burkina Faso. In addition, all data produced by the Nanoro
HDSS will be made publicly available through the INDEPTH data
sharing system. |
| Johanna H Kattenberg, Christian M Tahita, Inge A J Versteeg, Halidou Tinto, Maminata Traoré Coulibaly, Umberto D’Alessandro, Henk D F H Schallig, Petra F Mens Evaluation of antigen detection tests, microscopy, and
polymerase chain reaction for diagnosis of malaria in peripheral
blood in asymptomatic pregnant women in Nanoro, Burkina Faso (Journal Article) In: Am. J. Trop. Med. Hyg., vol. 87, no. 2, pp. 251–256, 2012. @article{Kattenberg2012-oz,
title = {Evaluation of antigen detection tests, microscopy, and
polymerase chain reaction for diagnosis of malaria in peripheral
blood in asymptomatic pregnant women in Nanoro, Burkina Faso},
author = {Johanna H Kattenberg and Christian M Tahita and Inge A J Versteeg and Halidou Tinto and Maminata Traor\'{e} Coulibaly and Umberto D'Alessandro and Henk D F H Schallig and Petra F Mens},
year = {2012},
date = {2012-08-01},
journal = {Am. J. Trop. Med. Hyg.},
volume = {87},
number = {2},
pages = {251--256},
publisher = {American Society of Tropical Medicine and Hygiene},
abstract = {Rapid diagnostics tests (RDTs) detect malaria specific
antigen(s) in the circulation, even when parasites are
sequestered in the placenta and not visible by microscopy.
However, research on their diagnostic accuracy during pregnancy is limited. Pregnant women (n = 418) were screened for malaria
during routine antenatal care by using two RDTs that detect
histidine-rich protein 2 (HRP2) or Plasmodium lactate
dehydrogenase, and enzyme-linked immunosorbent assays with
antibodies that detect dihydrofolate reductase-thymidylate
synthase or heme-detoxification protein, and compared with
real-time polymerase chain reaction (RT-PCR) and microscopy for
evaluation of their diagnostic accuracy. Prevalence of malaria
infection was high (53% by PCR). The RT-PCR and the HRP2 RDT
detected most cases of malaria during pregnancy, whereas
microscopy, the Plasmodium lactate dehydrogenase RDT, and
enzyme-linked immunosorbent assays for dihydrofolate
reductase-thymidylate synthase and heme-detoxification protein
antibodies did not detect several low-density infections.
Therefore, the HRP2 RDT could be a useful tool in
high-transmission areas for diagnosis of malaria in asymptomatic
pregnant women.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Rapid diagnostics tests (RDTs) detect malaria specific
antigen(s) in the circulation, even when parasites are
sequestered in the placenta and not visible by microscopy.
However, research on their diagnostic accuracy during pregnancy is limited. Pregnant women (n = 418) were screened for malaria
during routine antenatal care by using two RDTs that detect
histidine-rich protein 2 (HRP2) or Plasmodium lactate
dehydrogenase, and enzyme-linked immunosorbent assays with
antibodies that detect dihydrofolate reductase-thymidylate
synthase or heme-detoxification protein, and compared with
real-time polymerase chain reaction (RT-PCR) and microscopy for
evaluation of their diagnostic accuracy. Prevalence of malaria
infection was high (53% by PCR). The RT-PCR and the HRP2 RDT
detected most cases of malaria during pregnancy, whereas
microscopy, the Plasmodium lactate dehydrogenase RDT, and
enzyme-linked immunosorbent assays for dihydrofolate
reductase-thymidylate synthase and heme-detoxification protein
antibodies did not detect several low-density infections.
Therefore, the HRP2 RDT could be a useful tool in
high-transmission areas for diagnosis of malaria in asymptomatic
pregnant women. |
| Johanna H Kattenberg, Christian M Tahita, Inge A J Versteeg, Halidou Tinto, Maminata Traoré-Coulibaly, Henk D F H Schallig, Petra F Mens Antigen persistence of rapid diagnostic tests in pregnant women
in Nanoro, Burkina Faso, and the implications for the diagnosis
of malaria in pregnancy (Journal Article) In: Trop. Med. Int. Health, vol. 17, no. 5, pp. 550–557, 2012. @article{Kattenberg2012-hg,
title = {Antigen persistence of rapid diagnostic tests in pregnant women
in Nanoro, Burkina Faso, and the implications for the diagnosis
of malaria in pregnancy},
author = {Johanna H Kattenberg and Christian M Tahita and Inge A J Versteeg and Halidou Tinto and Maminata Traor\'{e}-Coulibaly and Henk D F H Schallig and Petra F Mens},
year = {2012},
date = {2012-05-01},
journal = {Trop. Med. Int. Health},
volume = {17},
number = {5},
pages = {550--557},
publisher = {Wiley},
abstract = {OBJECTIVES: To evaluate persistence of several Plasmodium
antigens in pregnant women after treatment and compare
diagnostics during treatment follow-up. METHODS: Thirty-two pregnant women (N = 32) with confirmed malaria infection by a
histidine-rich protein 2 (HRP2)-based rapid diagnostic test
(RDT) and microscopy were followed for 28 days after
artemisinin-based combination therapy (ACT). A Plasmodium
lactate dehydrogenase (pLDH)-based RDT and two ELISAs based on
the detection of dihydrofolate reductase-thymidylate synthase
(DHFR-TS) and haeme detoxification protein (HDP) were compared
with each other and to RT-PCR at each visit. RESULTS: The mean
visit number (95% confidence interval) on which the HRP2-based
RDT was still positive after treatment was 3.4 (2.7-4.1) visits
with some patients still positive at day 28. This is
significantly later than the pLDH-based RDT [0.84 (0.55-1.1)],
microscopy (median 1, range 1-3), DHFR-TS-ELISA [1.7 (1.1-2.3)]
and RT-PCR (median 2, range 1-5) (P < 0.05), but not
significantly later than HDP-ELISA [2.1 (1.6-2.7)]. Lower
gravidity and higher parasite density at day 0 resulted in
significantly longer positive results with most tests (P <
0.05). CONCLUSIONS: HRP2 can persist up to 28 days after ACT
treatment; therefore, this test is not suitable for treatment
follow-up in pregnant women and can generate problems when using
this test during intermittent preventive treatment (IPTp).
DHFR-TS is less persistent than HRP2, making it a potentially
interesting target for diagnosis.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
OBJECTIVES: To evaluate persistence of several Plasmodium
antigens in pregnant women after treatment and compare
diagnostics during treatment follow-up. METHODS: Thirty-two pregnant women (N = 32) with confirmed malaria infection by a
histidine-rich protein 2 (HRP2)-based rapid diagnostic test
(RDT) and microscopy were followed for 28 days after
artemisinin-based combination therapy (ACT). A Plasmodium
lactate dehydrogenase (pLDH)-based RDT and two ELISAs based on
the detection of dihydrofolate reductase-thymidylate synthase
(DHFR-TS) and haeme detoxification protein (HDP) were compared
with each other and to RT-PCR at each visit. RESULTS: The mean
visit number (95% confidence interval) on which the HRP2-based
RDT was still positive after treatment was 3.4 (2.7-4.1) visits
with some patients still positive at day 28. This is
significantly later than the pLDH-based RDT [0.84 (0.55-1.1)],
microscopy (median 1, range 1-3), DHFR-TS-ELISA [1.7 (1.1-2.3)]
and RT-PCR (median 2, range 1-5) (P < 0.05), but not
significantly later than HDP-ELISA [2.1 (1.6-2.7)]. Lower
gravidity and higher parasite density at day 0 resulted in
significantly longer positive results with most tests (P <
0.05). CONCLUSIONS: HRP2 can persist up to 28 days after ACT
treatment; therefore, this test is not suitable for treatment
follow-up in pregnant women and can generate problems when using
this test during intermittent preventive treatment (IPTp).
DHFR-TS is less persistent than HRP2, making it a potentially
interesting target for diagnosis. |
| Ronnatrai Rueangweerayut, Aung Pyae Phyo, Chirapong Uthaisin, Yi Poravuth, Tran Quang Binh, Halidou Tinto, Louis K Pénali, Neena Valecha, Nong Thi Tien, Salim Abdulla, Isabelle Borghini-Fuhrer, Stephan Duparc, Chang-Sik Shin, Lawrence Fleckenstein, Pyronaridine-Artesunate Study Team Pyronaridine-artesunate versus mefloquine plus artesunate for
malaria (Journal Article) In: N. Engl. J. Med., vol. 366, no. 14, pp. 1298–1309, 2012. @article{Rueangweerayut2012-is,
title = {Pyronaridine-artesunate versus mefloquine plus artesunate for
malaria},
author = {Ronnatrai Rueangweerayut and Aung Pyae Phyo and Chirapong Uthaisin and Yi Poravuth and Tran Quang Binh and Halidou Tinto and Louis K P\'{e}nali and Neena Valecha and Nong Thi Tien and Salim Abdulla and Isabelle Borghini-Fuhrer and Stephan Duparc and Chang-Sik Shin and Lawrence Fleckenstein and Pyronaridine-Artesunate Study Team},
year = {2012},
date = {2012-04-01},
journal = {N. Engl. J. Med.},
volume = {366},
number = {14},
pages = {1298--1309},
abstract = {BACKGROUND: Pyronaridine-artesunate is an artemisinin-based
combination therapy under evaluation for the treatment of
Plasmodium falciparum and P. vivax malaria. METHODS: We conducted
a phase 3, open-label, multicenter, noninferiority trial that
included 1271 patients between 3 and 60 years of age from Asia
(81.3%) or Africa (18.7%) with microscopically confirmed,
uncomplicated P. falciparum malaria. Patients underwent
randomization for treatment with a fixed-dose combination of 180
mg of pyronaridine and 60 mg of artesunate or with 250 mg of
mefloquine plus 100 mg of artesunate. Doses were calculated
according to body weight and administered once daily for 3 days.
RESULTS: Pyronaridine-artesunate was noninferior to mefloquine
plus artesunate for the primary outcome: adequate clinical and
parasitologic response in the per-protocol population on day 28,
corrected for reinfection with the use of
polymerase-chain-reaction (PCR) genotyping. For this outcome,
efficacy in the group receiving pyronaridine-artesunate was
99.2% (743 of 749 patients; 95% confidence interval [CI], 98.3
to 99.7) and that in the group receiving mefloquine plus
artesunate was 97.8% (360 of 368 patients; 95% CI, 95.8 to
99.1), with a treatment difference of 1.4 percentage points (95% CI, 0.0 to 3.5; P=0.05). In the intention-to-treat population,
efficacy on day 42 in the group receiving pyronaridine-artesunate
was 83.1% (705 of 848 patients; 95% CI, 80.4 to 85.6) and that
in the group receiving mefloquine plus artesunate was 83.9% (355
of 423 patients; 95% CI, 80.1 to 87.3). In Cambodia, where there
were 211 study patients, the median parasite clearance time was
prolonged for both treatments: 64 hours versus 16.0 to 38.9 hours
in other countries (P<0.001, on the basis of Kaplan-Meier
estimates). Kaplan-Meier estimates of the recrudescence rate in
the intention-to-treat population in Cambodia until day 42 were
higher with pyronaridine-artesunate than with mefloquine plus artesunate (10.2% [95% CI, 5.4 to 18.6] vs. 0%; P=0.04 as
calculated with the log-rank test), but similar for the other
countries combined (4.7% [95% CI, 3.3 to 6.7] and 2.8% [95% CI, 1.5 to 5.3], respectively; P=0.24). Elevated levels of
aminotransferases were observed in those receiving
pyronaridine-artesunate. Two patients receiving mefloquine plus
artesunate had seizures. CONCLUSIONS: Fixed-dose
pyronaridine-artesunate was efficacious in the treatment of
uncomplicated P. falciparum malaria. In Cambodia, extended
parasite clearance times were suggestive of in vivo resistance to
artemisinin. (Funded by Shin Poong Pharmaceutical Company and the
Medicines for Malaria Venture; ClinicalTrials.gov number,
NCT00403260.).},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND: Pyronaridine-artesunate is an artemisinin-based
combination therapy under evaluation for the treatment of
Plasmodium falciparum and P. vivax malaria. METHODS: We conducted
a phase 3, open-label, multicenter, noninferiority trial that
included 1271 patients between 3 and 60 years of age from Asia
(81.3%) or Africa (18.7%) with microscopically confirmed,
uncomplicated P. falciparum malaria. Patients underwent
randomization for treatment with a fixed-dose combination of 180
mg of pyronaridine and 60 mg of artesunate or with 250 mg of
mefloquine plus 100 mg of artesunate. Doses were calculated
according to body weight and administered once daily for 3 days.
RESULTS: Pyronaridine-artesunate was noninferior to mefloquine
plus artesunate for the primary outcome: adequate clinical and
parasitologic response in the per-protocol population on day 28,
corrected for reinfection with the use of
polymerase-chain-reaction (PCR) genotyping. For this outcome,
efficacy in the group receiving pyronaridine-artesunate was
99.2% (743 of 749 patients; 95% confidence interval [CI], 98.3
to 99.7) and that in the group receiving mefloquine plus
artesunate was 97.8% (360 of 368 patients; 95% CI, 95.8 to
99.1), with a treatment difference of 1.4 percentage points (95% CI, 0.0 to 3.5; P=0.05). In the intention-to-treat population,
efficacy on day 42 in the group receiving pyronaridine-artesunate
was 83.1% (705 of 848 patients; 95% CI, 80.4 to 85.6) and that
in the group receiving mefloquine plus artesunate was 83.9% (355
of 423 patients; 95% CI, 80.1 to 87.3). In Cambodia, where there
were 211 study patients, the median parasite clearance time was
prolonged for both treatments: 64 hours versus 16.0 to 38.9 hours
in other countries (P<0.001, on the basis of Kaplan-Meier
estimates). Kaplan-Meier estimates of the recrudescence rate in
the intention-to-treat population in Cambodia until day 42 were
higher with pyronaridine-artesunate than with mefloquine plus artesunate (10.2% [95% CI, 5.4 to 18.6] vs. 0%; P=0.04 as
calculated with the log-rank test), but similar for the other
countries combined (4.7% [95% CI, 3.3 to 6.7] and 2.8% [95% CI, 1.5 to 5.3], respectively; P=0.24). Elevated levels of
aminotransferases were observed in those receiving
pyronaridine-artesunate. Two patients receiving mefloquine plus
artesunate had seizures. CONCLUSIONS: Fixed-dose
pyronaridine-artesunate was efficacious in the treatment of
uncomplicated P. falciparum malaria. In Cambodia, extended
parasite clearance times were suggestive of in vivo resistance to
artemisinin. (Funded by Shin Poong Pharmaceutical Company and the
Medicines for Malaria Venture; ClinicalTrials.gov number,
NCT00403260.). |
| Innocent Valea, Halidou Tinto, Maxime K Drabo, Lieven Huybregts, Hermann Sorgho, Jean-Bosco Ouedraogo, Robert T Guiguemde, Jean Pierre Geertruyden, Patrick Kolsteren, Umberto D’Alessandro, FSP/MISAME Group An analysis of timing and frequency of malaria infection during
pregnancy in relation to the risk of low birth weight, anaemia
and perinatal mortality in Burkina Faso (Journal Article) In: Malar. J., vol. 11, no. 1, pp. 71, 2012. @article{Valea2012-pp,
title = {An analysis of timing and frequency of malaria infection during
pregnancy in relation to the risk of low birth weight, anaemia
and perinatal mortality in Burkina Faso},
author = {Innocent Valea and Halidou Tinto and Maxime K Drabo and Lieven Huybregts and Hermann Sorgho and Jean-Bosco Ouedraogo and Robert T Guiguemde and Jean Pierre Geertruyden and Patrick Kolsteren and Umberto D'Alessandro and FSP/MISAME Group},
year = {2012},
date = {2012-03-01},
journal = {Malar. J.},
volume = {11},
number = {1},
pages = {71},
publisher = {Springer Nature},
abstract = {BACKGROUND: A prospective study aiming at assessing the effect
of adding a third dose sulphadoxine-pyrimethamine (SP) to the
standard two-dose intermittent preventive treatment for pregnant
women was carried out in Hounde, Burkina Faso, between March
2006 and July 2008. Pregnant women were identified as earlier as
possible during pregnancy through a network of home visitors,
referred to the health facilities for inclusion and followed up
until delivery. METHODS: Study participants were enrolled at
antenatal care (ANC) visits and randomized to receive either two
or three doses of SP at the appropriate time. Women were visited
daily and a blood slide was collected when there was fever (body
temperature > 37.5°C) or history of fever. Women were encouraged
to attend ANC and deliver in the health centre, where the
new-born was examined and weighed. The timing and frequency of
malaria infection was analysed in relation to the risk of low
birth weight, maternal anaemia and perinatal mortality. RESULTS:
Data on birth weight and haemoglobin were available for 1,034
women. The incidence of malaria infections was significantly
lower in women having received three instead of two doses of SP.
Occurrence of first malaria infection during the first or second
trimester was associated with a higher risk of low birth weight: incidence rate ratios of 3.56 (p < 0.001) and 1.72 (p = 0.034),
respectively. After adjusting for possible confounding factors,
the risk remained significantly higher for the infection in the first trimester of pregnancy (adjusted incidence rate ratio = 2.0},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND: A prospective study aiming at assessing the effect
of adding a third dose sulphadoxine-pyrimethamine (SP) to the
standard two-dose intermittent preventive treatment for pregnant
women was carried out in Hounde, Burkina Faso, between March
2006 and July 2008. Pregnant women were identified as earlier as
possible during pregnancy through a network of home visitors,
referred to the health facilities for inclusion and followed up
until delivery. METHODS: Study participants were enrolled at
antenatal care (ANC) visits and randomized to receive either two
or three doses of SP at the appropriate time. Women were visited
daily and a blood slide was collected when there was fever (body
temperature > 37.5°C) or history of fever. Women were encouraged
to attend ANC and deliver in the health centre, where the
new-born was examined and weighed. The timing and frequency of
malaria infection was analysed in relation to the risk of low
birth weight, maternal anaemia and perinatal mortality. RESULTS:
Data on birth weight and haemoglobin were available for 1,034
women. The incidence of malaria infections was significantly
lower in women having received three instead of two doses of SP.
Occurrence of first malaria infection during the first or second
trimester was associated with a higher risk of low birth weight: incidence rate ratios of 3.56 (p < 0.001) and 1.72 (p = 0.034),
respectively. After adjusting for possible confounding factors,
the risk remained significantly higher for the infection in the first trimester of pregnancy (adjusted incidence rate ratio = 2.0 |
2011
|
Journal Articles
|
| S Clinical Trials Partnership RTS, Selidji Todagbe Agnandji, Bertrand Lell, Solange Solmeheim Soulanoudjingar, José Francisco Fernandes, Béatrice Peggy Abossolo, Cornelia Conzelmann, Barbara Gaelle Nfono Ondo Methogo, Yannick Doucka, Arnaud Flamen, Benjamin Mordmüller, Saadou Issifou, Peter Gottfried Kremsner, Jahit Sacarlal, Pedro Aide, Miguel Lanaspa, John J Aponte, Arlindo Nhamuave, Diana Quelhas, Quique Bassat, Sofia Mandjate, Eusébio Macete, Pedro Alonso, Salim Abdulla, Nahya Salim, Omar Juma, Mwanajaa Shomari, Kafuruki Shubis, Francisca Machera, Ali Said Hamad, Rose Minja, Ali Mtoro, Alma Sykes, Saumu Ahmed, Alwisa Martin Urassa, Ali Mohammed Ali, Grace Mwangoka, Marcel Tanner, Halidou Tinto, Umberto D’Alessandro, Hermann Sorgho, Innocent Valea, Marc Christian Tahita, William Kaboré, Sayouba Ouédraogo, Yara Sandrine, Robert Tinga Guiguemdé, Jean Bosco Ouédraogo, Mary J Hamel, Simon Kariuki, Chris Odero, Martina Oneko, Kephas Otieno, Norbert Awino, Jackton Omoto, John Williamson, Vincent Muturi-Kioi, Kayla F Laserson, Laurence Slutsker, Walter Otieno, Lucas Otieno, Otsyula Nekoye, Stacey Gondi, Allan Otieno, Bernhards Ogutu, Ruth Wasuna, Victorine Owira, David Jones, Agnes Akoth Onyango, Patricia Njuguna, Roma Chilengi, Pauline Akoo, Christine Kerubo, Jesse Gitaka, Charity Maingi, Trudie Lang, Ally Olotu, Benjamin Tsofa, Philip Bejon, Norbert Peshu, Kevin Marsh, Seth Owusu-Agyei, Kwaku Poku Asante, Kingsley Osei-Kwakye, Owusu Boahen, Samuel Ayamba, Kingsley Kayan, Ruth Owusu-Ofori, David Dosoo, Isaac Asante, George Adjei, George Adjei, Daniel Chandramohan, Brian Greenwood, John Lusingu, Samwel Gesase, Anangisye Malabeja, Omari Abdul, Hassan Kilavo, Coline Mahende, Edwin Liheluka, Martha Lemnge, Thor Theander, Chris Drakeley, Daniel Ansong, Tsiri Agbenyega, Samuel Adjei, Harry Owusu Boateng, Theresa Rettig, John Bawa, Justice Sylverken, David Sambian, Alex Agyekum, Larko Owusu, Francis Martinson, Irving Hoffman, Tisungane Mvalo, Portia Kamthunzi, Ruthendo Nkomo, Albans Msika, Allan Jumbe, Nelecy Chome, Dalitso Nyakuipa, Joseph Chintedza, W Ripley Ballou, Myriam Bruls, Joe Cohen, Yolanda Guerra, Erik Jongert, Didier Lapierre, Amanda Leach, Marc Lievens, Opokua Ofori-Anyinam, Johan Vekemans, Terrell Carter, Didier Leboulleux, Christian Loucq, Afiya Radford, Barbara Savarese, David Schellenberg, Marla Sillman, Preeti Vansadia First results of phase 3 trial of RTS,S/AS01 malaria vaccine
in African children (Journal Article) In: N. Engl. J. Med., vol. 365, no. 20, pp. 1863–1875, 2011. @article{RTSS_Clinical_Trials_Partnership2011-gv,
title = {First results of phase 3 trial of RTS,S/AS01 malaria vaccine
in African children},
author = {S Clinical Trials Partnership RTS and Selidji Todagbe Agnandji and Bertrand Lell and Solange Solmeheim Soulanoudjingar and Jos\'{e} Francisco Fernandes and B\'{e}atrice Peggy Abossolo and Cornelia Conzelmann and Barbara Gaelle Nfono Ondo Methogo and Yannick Doucka and Arnaud Flamen and Benjamin Mordm\"{u}ller and Saadou Issifou and Peter Gottfried Kremsner and Jahit Sacarlal and Pedro Aide and Miguel Lanaspa and John J Aponte and Arlindo Nhamuave and Diana Quelhas and Quique Bassat and Sofia Mandjate and Eus\'{e}bio Macete and Pedro Alonso and Salim Abdulla and Nahya Salim and Omar Juma and Mwanajaa Shomari and Kafuruki Shubis and Francisca Machera and Ali Said Hamad and Rose Minja and Ali Mtoro and Alma Sykes and Saumu Ahmed and Alwisa Martin Urassa and Ali Mohammed Ali and Grace Mwangoka and Marcel Tanner and Halidou Tinto and Umberto D'Alessandro and Hermann Sorgho and Innocent Valea and Marc Christian Tahita and William Kabor\'{e} and Sayouba Ou\'{e}draogo and Yara Sandrine and Robert Tinga Guiguemd\'{e} and Jean Bosco Ou\'{e}draogo and Mary J Hamel and Simon Kariuki and Chris Odero and Martina Oneko and Kephas Otieno and Norbert Awino and Jackton Omoto and John Williamson and Vincent Muturi-Kioi and Kayla F Laserson and Laurence Slutsker and Walter Otieno and Lucas Otieno and Otsyula Nekoye and Stacey Gondi and Allan Otieno and Bernhards Ogutu and Ruth Wasuna and Victorine Owira and David Jones and Agnes Akoth Onyango and Patricia Njuguna and Roma Chilengi and Pauline Akoo and Christine Kerubo and Jesse Gitaka and Charity Maingi and Trudie Lang and Ally Olotu and Benjamin Tsofa and Philip Bejon and Norbert Peshu and Kevin Marsh and Seth Owusu-Agyei and Kwaku Poku Asante and Kingsley Osei-Kwakye and Owusu Boahen and Samuel Ayamba and Kingsley Kayan and Ruth Owusu-Ofori and David Dosoo and Isaac Asante and George Adjei and George Adjei and Daniel Chandramohan and Brian Greenwood and John Lusingu and Samwel Gesase and Anangisye Malabeja and Omari Abdul and Hassan Kilavo and Coline Mahende and Edwin Liheluka and Martha Lemnge and Thor Theander and Chris Drakeley and Daniel Ansong and Tsiri Agbenyega and Samuel Adjei and Harry Owusu Boateng and Theresa Rettig and John Bawa and Justice Sylverken and David Sambian and Alex Agyekum and Larko Owusu and Francis Martinson and Irving Hoffman and Tisungane Mvalo and Portia Kamthunzi and Ruthendo Nkomo and Albans Msika and Allan Jumbe and Nelecy Chome and Dalitso Nyakuipa and Joseph Chintedza and W Ripley Ballou and Myriam Bruls and Joe Cohen and Yolanda Guerra and Erik Jongert and Didier Lapierre and Amanda Leach and Marc Lievens and Opokua Ofori-Anyinam and Johan Vekemans and Terrell Carter and Didier Leboulleux and Christian Loucq and Afiya Radford and Barbara Savarese and David Schellenberg and Marla Sillman and Preeti Vansadia},
year = {2011},
date = {2011-11-01},
journal = {N. Engl. J. Med.},
volume = {365},
number = {20},
pages = {1863--1875},
publisher = {New England Journal of Medicine (NEJM/MMS)},
abstract = {BACKGROUND: An ongoing phase 3 study of the efficacy, safety,
and immunogenicity of candidate malaria vaccine RTS,S/AS01 is
being conducted in seven African countries. METHODS: From March
2009 through January 2011, we enrolled 15,460 children in two
age categories--6 to 12 weeks of age and 5 to 17 months of
age--for vaccination with either RTS,S/AS01 or a non-malaria
comparator vaccine. The primary end point of the analysis was
vaccine efficacy against clinical malaria during the 12 months
after vaccination in the first 6000 children 5 to 17 months of
age at enrollment who received all three doses of vaccine
according to protocol. After 250 children had an episode of
severe malaria, we evaluated vaccine efficacy against severe
malaria in both age categories. RESULTS: In the 14 months after
the first dose of vaccine, the incidence of first episodes of
clinical malaria in the first 6000 children in the older age
category was 0.32 episodes per person-year in the RTS,S/AS01
group and 0.55 episodes per person-year in the control group,
for an efficacy of 50.4% (95% confidence interval [CI], 45.8
to 54.6) in the intention-to-treat population and 55.8% (97.5%
CI, 50.6 to 60.4) in the per-protocol population. Vaccine
efficacy against severe malaria was 45.1% (95% CI, 23.8 to
60.5) in the intention-to-treat population and 47.3% (95% CI,
22.4 to 64.2) in the per-protocol population. Vaccine efficacy
against severe malaria in the combined age categories was 34.8%
(95% CI, 16.2 to 49.2) in the per-protocol population during an
average follow-up of 11 months. Serious adverse events occurred
with a similar frequency in the two study groups. Among children
in the older age category, the rate of generalized convulsive
seizures after RTS,S/AS01 vaccination was 1.04 per 1000 doses
(95% CI, 0.62 to 1.64). CONCLUSIONS: The RTS,S/AS01 vaccine
provided protection against both clinical and severe malaria in
African children. (Funded by GlaxoSmithKline Biologicals and the
PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov
number, NCT00866619 .).},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND: An ongoing phase 3 study of the efficacy, safety,
and immunogenicity of candidate malaria vaccine RTS,S/AS01 is
being conducted in seven African countries. METHODS: From March
2009 through January 2011, we enrolled 15,460 children in two
age categories–6 to 12 weeks of age and 5 to 17 months of
age–for vaccination with either RTS,S/AS01 or a non-malaria
comparator vaccine. The primary end point of the analysis was
vaccine efficacy against clinical malaria during the 12 months
after vaccination in the first 6000 children 5 to 17 months of
age at enrollment who received all three doses of vaccine
according to protocol. After 250 children had an episode of
severe malaria, we evaluated vaccine efficacy against severe
malaria in both age categories. RESULTS: In the 14 months after
the first dose of vaccine, the incidence of first episodes of
clinical malaria in the first 6000 children in the older age
category was 0.32 episodes per person-year in the RTS,S/AS01
group and 0.55 episodes per person-year in the control group,
for an efficacy of 50.4% (95% confidence interval [CI], 45.8
to 54.6) in the intention-to-treat population and 55.8% (97.5%
CI, 50.6 to 60.4) in the per-protocol population. Vaccine
efficacy against severe malaria was 45.1% (95% CI, 23.8 to
60.5) in the intention-to-treat population and 47.3% (95% CI,
22.4 to 64.2) in the per-protocol population. Vaccine efficacy
against severe malaria in the combined age categories was 34.8%
(95% CI, 16.2 to 49.2) in the per-protocol population during an
average follow-up of 11 months. Serious adverse events occurred
with a similar frequency in the two study groups. Among children
in the older age category, the rate of generalized convulsive
seizures after RTS,S/AS01 vaccination was 1.04 per 1000 doses
(95% CI, 0.62 to 1.64). CONCLUSIONS: The RTS,S/AS01 vaccine
provided protection against both clinical and severe malaria in
African children. (Funded by GlaxoSmithKline Biologicals and the
PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov
number, NCT00866619 .). |
| Zeno Bisoffi, Sodiomon B Sirima, Filip Meheus, Claudia Lodesani, Federico Gobbi, Andrea Angheben, Halidou Tinto, Bouma Neya, Klara Van den Ende, Annalisa Romeo, Jef Van den Ende Strict adherence to malaria rapid test results might lead to a
neglect of other dangerous diseases: a cost benefit analysis
from Burkina Faso (Journal Article) In: Malar. J., vol. 10, no. 1, pp. 226, 2011. @article{Bisoffi2011-dn,
title = {Strict adherence to malaria rapid test results might lead to a
neglect of other dangerous diseases: a cost benefit analysis
from Burkina Faso},
author = {Zeno Bisoffi and Sodiomon B Sirima and Filip Meheus and Claudia Lodesani and Federico Gobbi and Andrea Angheben and Halidou Tinto and Bouma Neya and Klara Van den Ende and Annalisa Romeo and Jef Van den Ende},
year = {2011},
date = {2011-08-01},
journal = {Malar. J.},
volume = {10},
number = {1},
pages = {226},
publisher = {Springer Nature},
abstract = {BACKGROUND: Malaria rapid diagnostic tests (RDTs) have generally
been found reliable and cost-effective. In Burkina Faso, the
adherence of prescribers to the negative test result was found
to be poor. Moreover, the test accuracy for malaria-attributable
fever (MAF) is not the same as for malaria infection. This paper
aims at determining the costs and benefits of two competing
strategies for the management of MAF: presumptive treatment for
all or use of RDTs. METHODS: A cost benefit analysis was carried
out using a decision tree, based on data previously obtained,
including a randomized controlled trial (RCT) recruiting 852
febrile patients during the dry season and 1,317 in the rainy
season. Cost and benefit were calculated using both the real
adherence found by the RCT and assuming an ideal adherence of
90% with the negative result. The main parameters were
submitted to sensitivity analysis. RESULTS AND DISCUSSION: At
real adherence, the test-based strategy was dominated. Assuming
ideal adherence, at the value of 525 € for a death averted, the
total cost of managing 1,000 febrile children was 1,747 vs.
1,862 € in the dry season and 1,372 vs. 2,138 in the rainy
season for the presumptive vs. the test-based strategy. For
adults it was 2,728 vs. 1,983 and 2,604 vs. 2,225, respectively.
At the subsidized policy adopted locally, assuming ideal
adherence, the RDT would be the winning strategy for adults in
both seasons and for children in the dry season.At sensitivity
analysis, the factors most influencing the choice of the better
strategy were the value assigned to a death averted and the
proportion of potentially severe NMFI treated with antibiotics
in patients with false positive RDT results. The test-based
strategy appears advantageous for adults if a satisfactory
adherence could be achieved. For children the presumptive
strategy remains the best choice for a wide range of scenarios.
CONCLUSIONS: For RDTs to be preferred, a positive result should
not influence the decision to treat a potentially severe NMFI
with antibiotics. In the rainy season the presumptive strategy
always remains the better choice for children.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND: Malaria rapid diagnostic tests (RDTs) have generally
been found reliable and cost-effective. In Burkina Faso, the
adherence of prescribers to the negative test result was found
to be poor. Moreover, the test accuracy for malaria-attributable
fever (MAF) is not the same as for malaria infection. This paper
aims at determining the costs and benefits of two competing
strategies for the management of MAF: presumptive treatment for
all or use of RDTs. METHODS: A cost benefit analysis was carried
out using a decision tree, based on data previously obtained,
including a randomized controlled trial (RCT) recruiting 852
febrile patients during the dry season and 1,317 in the rainy
season. Cost and benefit were calculated using both the real
adherence found by the RCT and assuming an ideal adherence of
90% with the negative result. The main parameters were
submitted to sensitivity analysis. RESULTS AND DISCUSSION: At
real adherence, the test-based strategy was dominated. Assuming
ideal adherence, at the value of 525 € for a death averted, the
total cost of managing 1,000 febrile children was 1,747 vs.
1,862 € in the dry season and 1,372 vs. 2,138 in the rainy
season for the presumptive vs. the test-based strategy. For
adults it was 2,728 vs. 1,983 and 2,604 vs. 2,225, respectively.
At the subsidized policy adopted locally, assuming ideal
adherence, the RDT would be the winning strategy for adults in
both seasons and for children in the dry season.At sensitivity
analysis, the factors most influencing the choice of the better
strategy were the value assigned to a death averted and the
proportion of potentially severe NMFI treated with antibiotics
in patients with false positive RDT results. The test-based
strategy appears advantageous for adults if a satisfactory
adherence could be achieved. For children the presumptive
strategy remains the best choice for a wide range of scenarios.
CONCLUSIONS: For RDTs to be preferred, a positive result should
not influence the decision to treat a potentially severe NMFI
with antibiotics. In the rainy season the presumptive strategy
always remains the better choice for children. |
| Christine Swysen, Johan Vekemans, Myriam Bruls, Sunny Oyakhirome, Chris Drakeley, Peter Kremsner, Brian Greenwood, Opokua Ofori-Anyinam, Brenda Okech, Tonya Villafana, Terrell Carter, Barbara Savarese, Adriano Duse, Andrea Reijman, Charlotte Ingram, John Frean, Bernhards Ogutu, Clinical Trials Partnership Committee Development of standardized laboratory methods and quality
processes for a phase III study of the RTS, S/AS01
candidate malaria vaccine (Journal Article) In: Malar. J., vol. 10, no. 1, pp. 223, 2011. @article{Swysen2011-lr,
title = {Development of standardized laboratory methods and quality
processes for a phase III study of the RTS, S/AS01
candidate malaria vaccine},
author = {Christine Swysen and Johan Vekemans and Myriam Bruls and Sunny Oyakhirome and Chris Drakeley and Peter Kremsner and Brian Greenwood and Opokua Ofori-Anyinam and Brenda Okech and Tonya Villafana and Terrell Carter and Barbara Savarese and Adriano Duse and Andrea Reijman and Charlotte Ingram and John Frean and Bernhards Ogutu and Clinical Trials Partnership Committee},
year = {2011},
date = {2011-08-01},
journal = {Malar. J.},
volume = {10},
number = {1},
pages = {223},
publisher = {Springer Nature},
abstract = {BACKGROUND: A pivotal phase III study of the RTS,S/AS01 malaria
candidate vaccine is ongoing in several research centres across
Africa. The development and establishment of quality systems was
a requirement for trial conduct to meet international regulatory
standards, as well as providing an important capacity
strengthening opportunity for study centres. METHODS:
Standardized laboratory methods and quality assurance processes
were implemented at each of the study centres, facilitated by
funding partners. RESULTS: A robust protocol for determination
of parasite density based on actual blood cell counts was set up
in accordance with World Health Organization recommendations.
Automated equipment including haematology and biochemistry
analyzers were put in place with standard methods for bedside
testing of glycaemia, base excess and lactacidaemia. Facilities
for X-rays and basic microbiology testing were also provided or
upgraded alongside health care infrastructure in some centres.
External quality assurance assessment of all major laboratory
methods was established and method qualification by each
laboratory demonstrated. The resulting capacity strengthening
has ensured laboratory evaluations are conducted locally to the
high standards required in clinical trials. CONCLUSION: Major
efforts by study centres, together with support from
collaborating parties, have allowed standardized methods and
robust quality assurance processes to be put in place for the
phase III evaluation of the RTS, S/AS01 malaria candidate
vaccine. Extensive training programmes, coupled with continuous
commitment from research centre staff, have been the key
elements behind the successful implementation of quality
processes. It is expected these activities will culminate in
healthcare benefits for the subjects and communities
participating in these trials. TRIAL REGISTRATION:
Clinicaltrials.gov NCT00866619.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND: A pivotal phase III study of the RTS,S/AS01 malaria
candidate vaccine is ongoing in several research centres across
Africa. The development and establishment of quality systems was
a requirement for trial conduct to meet international regulatory
standards, as well as providing an important capacity
strengthening opportunity for study centres. METHODS:
Standardized laboratory methods and quality assurance processes
were implemented at each of the study centres, facilitated by
funding partners. RESULTS: A robust protocol for determination
of parasite density based on actual blood cell counts was set up
in accordance with World Health Organization recommendations.
Automated equipment including haematology and biochemistry
analyzers were put in place with standard methods for bedside
testing of glycaemia, base excess and lactacidaemia. Facilities
for X-rays and basic microbiology testing were also provided or
upgraded alongside health care infrastructure in some centres.
External quality assurance assessment of all major laboratory
methods was established and method qualification by each
laboratory demonstrated. The resulting capacity strengthening
has ensured laboratory evaluations are conducted locally to the
high standards required in clinical trials. CONCLUSION: Major
efforts by study centres, together with support from
collaborating parties, have allowed standardized methods and
robust quality assurance processes to be put in place for the
phase III evaluation of the RTS, S/AS01 malaria candidate
vaccine. Extensive training programmes, coupled with continuous
commitment from research centre staff, have been the key
elements behind the successful implementation of quality
processes. It is expected these activities will culminate in
healthcare benefits for the subjects and communities
participating in these trials. TRIAL REGISTRATION:
Clinicaltrials.gov NCT00866619. |
| Raffaella Ravinetto, Anne Buvé, Tinto Halidou, Pascal Lutumba, Ambrose Talisuna, Mohammad Juffrie, Umberto D’Alessandro, Marleen Boelaert Double ethical review of North-South collaborative clinical
research: hidden paternalism or real partnership? (Journal Article) In: Trop. Med. Int. Health, vol. 16, no. 4, pp. 527–530, 2011. @article{Ravinetto2011-tb,
title = {Double ethical review of North-South collaborative clinical
research: hidden paternalism or real partnership?},
author = {Raffaella Ravinetto and Anne Buv\'{e} and Tinto Halidou and Pascal Lutumba and Ambrose Talisuna and Mohammad Juffrie and Umberto D'Alessandro and Marleen Boelaert},
year = {2011},
date = {2011-04-01},
journal = {Trop. Med. Int. Health},
volume = {16},
number = {4},
pages = {527--530},
publisher = {Wiley},
abstract = {Despite their universal character, the ethical principles
governing clinical research need to be translated into
procedures and practices, which will vary among countries and
regions because of differences in local cultural norms and in
the available resources. Double ethical review, by which a
research protocol is submitted for ethical clearance both in the
country or countries where the research takes place and in the
country of the sponsor or funding agency, will then help ensure
that all relevant perspectives are taken into account. In
addition, a geographically and culturally close ethics committee
can do a much better informed and comprehensive assessment of
the respective skills of the clinical sites and of the sponsor.
But the practical implementation of double ethical review can
bring significant difficulties and delays, especially in
multi-site and multi-country researches. Currently, most ethics
committees do not proactively seek communication with others
evaluating the same research protocol in different
socio-economical and cultural contexts, so in practice there is
no mutual learning process. Proactive communication would help
to build collaborative partnership among ethical bodies,
promoting common practices and resolving conflicting opinions.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Despite their universal character, the ethical principles
governing clinical research need to be translated into
procedures and practices, which will vary among countries and
regions because of differences in local cultural norms and in
the available resources. Double ethical review, by which a
research protocol is submitted for ethical clearance both in the
country or countries where the research takes place and in the
country of the sponsor or funding agency, will then help ensure
that all relevant perspectives are taken into account. In
addition, a geographically and culturally close ethics committee
can do a much better informed and comprehensive assessment of
the respective skills of the clinical sites and of the sponsor.
But the practical implementation of double ethical review can
bring significant difficulties and delays, especially in
multi-site and multi-country researches. Currently, most ethics
committees do not proactively seek communication with others
evaluating the same research protocol in different
socio-economical and cultural contexts, so in practice there is
no mutual learning process. Proactive communication would help
to build collaborative partnership among ethical bodies,
promoting common practices and resolving conflicting opinions. |
2010
|
Journal Articles
|
| Innocent Valea, Halidou Tinto, Maxime K Drabo, Lieven Huybregts, Marie-Claire Henry, Dominique Roberfroid, Robert T Guiguemde, Patrick Kolsteren, Umberto D’Alessandro, FSP/MISAME Group Intermittent preventive treatment of malaria with
sulphadoxine-pyrimethamine during pregnancy in Burkina Faso:
effect of adding a third dose to the standard two-dose regimen
on low birth weight, anaemia and pregnancy outcomes (Journal Article) In: Malar. J., vol. 9, no. 1, pp. 324, 2010. @article{Valea2010-af,
title = {Intermittent preventive treatment of malaria with
sulphadoxine-pyrimethamine during pregnancy in Burkina Faso:
effect of adding a third dose to the standard two-dose regimen
on low birth weight, anaemia and pregnancy outcomes},
author = {Innocent Valea and Halidou Tinto and Maxime K Drabo and Lieven Huybregts and Marie-Claire Henry and Dominique Roberfroid and Robert T Guiguemde and Patrick Kolsteren and Umberto D'Alessandro and FSP/MISAME Group},
year = {2010},
date = {2010-11-01},
journal = {Malar. J.},
volume = {9},
number = {1},
pages = {324},
publisher = {Springer Nature},
abstract = {BACKGROUND: Intermittent preventive treatment with
sulphadoxine-pyrimethamine (IPTp-SP) is being implemented in
most malaria endemic countries as a standard two-doses regimen
as it reduces the risk of low birth weight (LBW) and the
prevalence of maternal anaemia. Nevertheless, where the risk of
infection close to delivery is high because of intense
transmission, a third IPTp-SP dose may further reduce the
negative effects of malaria on pregnancy outcome. METHODS:
Pregnant women in the 2nd or 3rd trimester were randomized to
receive either 2 (SP2) or 3 doses (SP3) of SP. Trained field
workers paid home visits to the women for drug administration
according to a predefined drug delivery schedule. Women were
encouraged to attend their scheduled ANC visits and to deliver
at the health facilities where the new-born was weighed. The
prevalence of LBW (<2500 g), severe anaemia (Hb < 8 g/dL) and
premature birth was analysed using intention-to-treat (ITT) and
per-protocol (PP) analysis. RESULTS: Data from 1274 singleton
pregnancies were analysed (641 in the SP3 and 633 in the SP2
group). The uptake of the intervention appeared to be low.
Though the prevalence of LBW in both intervention groups was similar (adjusted Incident Rate Rati},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND: Intermittent preventive treatment with
sulphadoxine-pyrimethamine (IPTp-SP) is being implemented in
most malaria endemic countries as a standard two-doses regimen
as it reduces the risk of low birth weight (LBW) and the
prevalence of maternal anaemia. Nevertheless, where the risk of
infection close to delivery is high because of intense
transmission, a third IPTp-SP dose may further reduce the
negative effects of malaria on pregnancy outcome. METHODS:
Pregnant women in the 2nd or 3rd trimester were randomized to
receive either 2 (SP2) or 3 doses (SP3) of SP. Trained field
workers paid home visits to the women for drug administration
according to a predefined drug delivery schedule. Women were
encouraged to attend their scheduled ANC visits and to deliver
at the health facilities where the new-born was weighed. The
prevalence of LBW (<2500 g), severe anaemia (Hb < 8 g/dL) and
premature birth was analysed using intention-to-treat (ITT) and
per-protocol (PP) analysis. RESULTS: Data from 1274 singleton
pregnancies were analysed (641 in the SP3 and 633 in the SP2
group). The uptake of the intervention appeared to be low.
Though the prevalence of LBW in both intervention groups was similar (adjusted Incident Rate Rati |
| Zeno Bisoffi, Sodiomon B Sirima, Joris Menten, Cristian Pattaro, Andrea Angheben, Federico Gobbi, Halidou Tinto, Claudia Lodesani, Bouma Neya, Maria Gobbo, Jef Van den Ende Accuracy of a rapid diagnostic test on the diagnosis of malaria
infection and of malaria-attributable fever during low and high
transmission season in Burkina Faso (Journal Article) In: Malar. J., vol. 9, no. 1, pp. 192, 2010. @article{Bisoffi2010-jd,
title = {Accuracy of a rapid diagnostic test on the diagnosis of malaria
infection and of malaria-attributable fever during low and high
transmission season in Burkina Faso},
author = {Zeno Bisoffi and Sodiomon B Sirima and Joris Menten and Cristian Pattaro and Andrea Angheben and Federico Gobbi and Halidou Tinto and Claudia Lodesani and Bouma Neya and Maria Gobbo and Jef Van den Ende},
year = {2010},
date = {2010-07-01},
journal = {Malar. J.},
volume = {9},
number = {1},
pages = {192},
publisher = {Springer Nature},
abstract = {BACKGROUND: Malaria management policies currently recommend that
the treatment should only be administered after laboratory
confirmation. Where microscopy is not available, rapid
diagnostic tests (RDTs) are the usual alternative. Conclusive
evidence is still lacking on the safety of a test-based strategy
for children. Moreover, no formal attempt has been made to
estimate RDTs accuracy on malaria-attributable fever. This study
aims at estimating the accuracy of a RDT for the diagnosis of
both malaria infection and malaria - attributable fever, in a
region of Burkina Faso with a typically seasonal malaria
transmission pattern. METHODS: Cross-sectional study. SUBJECTS:
all patients aged > 6 months consulting during the study
periods. Gold standard for the diagnosis of malaria infection
was microscopy. Gold standard for malaria-attributable fever was
the number of fevers attributable to malaria, estimated by
comparing parasite densities of febrile versus non-febrile
subjects. EXCLUSION CRITERIA: severe clinical condition needing
urgent care. RESULTS: In the dry season, 186/852 patients with
fever (22%) and 213/1,382 patients without fever (15%) had a
Plasmodium falciparum infection. In the rainy season, this
proportion was 841/1,317 (64%) and 623/1,669 (37%),
respectively. The attributable fraction of fever to malaria was
11% and 69%, respectively. The RDT was positive in 113/400
(28.3%) fever cases in the dry season, and in 443/650 (68.2%)
in the rainy season. In the dry season, the RDT sensitivity and
specificity for malaria infection were 86% and 90%
respectively. In the rainy season they were 94% and 78%
respectively. In the dry season, the RDT sensitivity and
specificity for malaria-attributable fever were 94% and 75%,
the positive predictive value (PPV) was 9% and the negative
predictive value (NPV) was 99.8%. In the rainy season the test
sensitivity for malaria-attributable fever was 97% and
specificity was 55%. The PPV ranged from 38% for adults to
82% for infants, while the NPV ranged from 84% for infants to
over 99% for adults. CONCLUSIONS: In the dry season the RDT has
a low positive predictive value, but a very high negative
predictive value for malaria-attributable fever. In the rainy
season the negative test safely excludes malaria in adults but
not in children.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND: Malaria management policies currently recommend that
the treatment should only be administered after laboratory
confirmation. Where microscopy is not available, rapid
diagnostic tests (RDTs) are the usual alternative. Conclusive
evidence is still lacking on the safety of a test-based strategy
for children. Moreover, no formal attempt has been made to
estimate RDTs accuracy on malaria-attributable fever. This study
aims at estimating the accuracy of a RDT for the diagnosis of
both malaria infection and malaria – attributable fever, in a
region of Burkina Faso with a typically seasonal malaria
transmission pattern. METHODS: Cross-sectional study. SUBJECTS:
all patients aged > 6 months consulting during the study
periods. Gold standard for the diagnosis of malaria infection
was microscopy. Gold standard for malaria-attributable fever was
the number of fevers attributable to malaria, estimated by
comparing parasite densities of febrile versus non-febrile
subjects. EXCLUSION CRITERIA: severe clinical condition needing
urgent care. RESULTS: In the dry season, 186/852 patients with
fever (22%) and 213/1,382 patients without fever (15%) had a
Plasmodium falciparum infection. In the rainy season, this
proportion was 841/1,317 (64%) and 623/1,669 (37%),
respectively. The attributable fraction of fever to malaria was
11% and 69%, respectively. The RDT was positive in 113/400
(28.3%) fever cases in the dry season, and in 443/650 (68.2%)
in the rainy season. In the dry season, the RDT sensitivity and
specificity for malaria infection were 86% and 90%
respectively. In the rainy season they were 94% and 78%
respectively. In the dry season, the RDT sensitivity and
specificity for malaria-attributable fever were 94% and 75%,
the positive predictive value (PPV) was 9% and the negative
predictive value (NPV) was 99.8%. In the rainy season the test
sensitivity for malaria-attributable fever was 97% and
specificity was 55%. The PPV ranged from 38% for adults to
82% for infants, while the NPV ranged from 84% for infants to
over 99% for adults. CONCLUSIONS: In the dry season the RDT has
a low positive predictive value, but a very high negative
predictive value for malaria-attributable fever. In the rainy
season the negative test safely excludes malaria in adults but
not in children. |
2009
|
Journal Articles
|
| Quique Bassat, Modest Mulenga, Halidou Tinto, Patrice Piola, Steffen Borrmann, Clara Menéndez, Michael Nambozi, Innocent Valéa, Carolyn Nabasumba, Philip Sasi, Antonella Bacchieri, Marco Corsi, David Ubben, Ambrose Talisuna, Umberto D’Alessandro Dihydroartemisinin-piperaquine and artemether-lumefantrine for
treating uncomplicated malaria in African children: a
randomised, non-inferiority trial (Journal Article) In: PLoS One, vol. 4, no. 11, pp. e7871, 2009. @article{Bassat2009-xq,
title = {Dihydroartemisinin-piperaquine and artemether-lumefantrine for
treating uncomplicated malaria in African children: a
randomised, non-inferiority trial},
author = {Quique Bassat and Modest Mulenga and Halidou Tinto and Patrice Piola and Steffen Borrmann and Clara Men\'{e}ndez and Michael Nambozi and Innocent Val\'{e}a and Carolyn Nabasumba and Philip Sasi and Antonella Bacchieri and Marco Corsi and David Ubben and Ambrose Talisuna and Umberto D'Alessandro},
year = {2009},
date = {2009-11-01},
journal = {PLoS One},
volume = {4},
number = {11},
pages = {e7871},
publisher = {Public Library of Science (PLoS)},
abstract = {BACKGROUND: Artemisinin combination therapies (ACTs) are
currently the preferred option for treating uncomplicated
malaria. Dihydroartemisinin-piperaquine (DHA-PQP) is a promising
fixed-dose ACT with limited information on its safety and
efficacy in African children. METHODOLOGY/PRINCIPAL FINDINGS:
The non-inferiority of DHA-PQP versus artemether-lumefantrine
(AL) in children 6-59 months old with uncomplicated P.
falciparum malaria was tested in five African countries (Burkina
Faso, Kenya, Mozambique, Uganda and Zambia). Patients were
randomised (2:1) to receive either DHA-PQP or AL.
Non-inferiority was assessed using a margin of -5% for the
lower limit of the one-sided 97.5% confidence interval on the
treatment difference (DHA-PQP vs. AL) of the day 28 polymerase
chain reaction (PCR) corrected cure rate. Efficacy analysis was
performed in several populations, and two of them are presented
here: intention-to-treat (ITT) and enlarged per-protocol (ePP).
1553 children were randomised, 1039 receiving DHA-PQP and 514
AL. The PCR-corrected day 28 cure rate was 90.4% (ITT) and
94.7% (ePP) in the DHA-PQP group, and 90.0% (ITT) and 95.3%
(ePP) in the AL group. The lower limits of the one-sided 97.5%
CI of the difference between the two treatments were -2.80% and
-2.96%, in the ITT and ePP populations, respectively. In the
ITT population, the Kaplan-Meier estimate of the proportion of
new infections up to Day 42 was 13.55% (95% CI:
11.35%-15.76%) for DHA-PQP vs 24.00% (95% CI:
20.11%-27.88%) for AL (p<0.0001). CONCLUSIONS/SIGNIFICANCE:
DHA-PQP is as efficacious as AL in treating uncomplicated
malaria in African children from different endemicity settings,
and shows a comparable safety profile. The occurrence of new
infections within the 42-day follow up was significantly lower
in the DHA-PQP group, indicating a longer post-treatment
prophylactic effect. TRIAL REGISTRATION: Controlled-trials.com
ISRCTN16263443.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND: Artemisinin combination therapies (ACTs) are
currently the preferred option for treating uncomplicated
malaria. Dihydroartemisinin-piperaquine (DHA-PQP) is a promising
fixed-dose ACT with limited information on its safety and
efficacy in African children. METHODOLOGY/PRINCIPAL FINDINGS:
The non-inferiority of DHA-PQP versus artemether-lumefantrine
(AL) in children 6-59 months old with uncomplicated P.
falciparum malaria was tested in five African countries (Burkina
Faso, Kenya, Mozambique, Uganda and Zambia). Patients were
randomised (2:1) to receive either DHA-PQP or AL.
Non-inferiority was assessed using a margin of -5% for the
lower limit of the one-sided 97.5% confidence interval on the
treatment difference (DHA-PQP vs. AL) of the day 28 polymerase
chain reaction (PCR) corrected cure rate. Efficacy analysis was
performed in several populations, and two of them are presented
here: intention-to-treat (ITT) and enlarged per-protocol (ePP).
1553 children were randomised, 1039 receiving DHA-PQP and 514
AL. The PCR-corrected day 28 cure rate was 90.4% (ITT) and
94.7% (ePP) in the DHA-PQP group, and 90.0% (ITT) and 95.3%
(ePP) in the AL group. The lower limits of the one-sided 97.5%
CI of the difference between the two treatments were -2.80% and
-2.96%, in the ITT and ePP populations, respectively. In the
ITT population, the Kaplan-Meier estimate of the proportion of
new infections up to Day 42 was 13.55% (95% CI:
11.35%-15.76%) for DHA-PQP vs 24.00% (95% CI:
20.11%-27.88%) for AL (p<0.0001). CONCLUSIONS/SIGNIFICANCE:
DHA-PQP is as efficacious as AL in treating uncomplicated
malaria in African children from different endemicity settings,
and shows a comparable safety profile. The occurrence of new
infections within the 42-day follow up was significantly lower
in the DHA-PQP group, indicating a longer post-treatment
prophylactic effect. TRIAL REGISTRATION: Controlled-trials.com
ISRCTN16263443. |
| Zeno Bisoffi, Bienvenu Sodiomon Sirima, Andrea Angheben, Claudia Lodesani, Federico Gobbi, Halidou Tinto, Jef Van den Ende Rapid malaria diagnostic tests vs. clinical management of
malaria in rural Burkina Faso: safety and effect on clinical
decisions. A randomized trial (Journal Article) In: Trop. Med. Int. Health, vol. 14, no. 5, pp. 491–498, 2009. @article{Bisoffi2009-zh,
title = {Rapid malaria diagnostic tests vs. clinical management of
malaria in rural Burkina Faso: safety and effect on clinical
decisions. A randomized trial},
author = {Zeno Bisoffi and Bienvenu Sodiomon Sirima and Andrea Angheben and Claudia Lodesani and Federico Gobbi and Halidou Tinto and Jef Van den Ende},
year = {2009},
date = {2009-05-01},
journal = {Trop. Med. Int. Health},
volume = {14},
number = {5},
pages = {491--498},
publisher = {Wiley},
abstract = {OBJECTIVES: To assess if the clinical outcome of patients
treated after performing a Rapid Diagnostic Test for malaria
(RDT) is at least equivalent to that of controls (treated
presumptively without test) and to determine the impact of the
introduction of a malaria RDT on clinical decisions. METHODS:
Randomized, multi-centre, open clinical trial in two arms in
2006 at the end of the dry and of the rainy season in 10
peripheral health centres in Burkina Faso: one arm with use of
RDT before treatment decision, one arm managed clinically.
Primary endpoint: persistence of fever at day 4. Secondary
endpoints: frequency of malaria treatment and of antibiotic
treatment. RESULTS: A total of 852 febrile patients were
recruited in the dry season and 1317 febrile patients in the
rainy season, and randomized either to be submitted to RDT
(P_RTD) or to be managed presumptively (P_CLIN). In both
seasons, no significant difference was found between the two
randomized groups in the frequency of antimalarial treatment,
nor of antibiotic prescription. In the dry season, 80.8% and
79.8% of patients with a negative RDT were nevertheless
diagnosed and treated for malaria, and so were 85.0% and 82.6%
negative patients in the rainy season. In the rainy season only,
both diagnosis and treatment of other conditions were
significantly less frequent in RDT positive vs. negative patients (48.3% vs. 61.4% and 46.2% vs. 59.9},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
OBJECTIVES: To assess if the clinical outcome of patients
treated after performing a Rapid Diagnostic Test for malaria
(RDT) is at least equivalent to that of controls (treated
presumptively without test) and to determine the impact of the
introduction of a malaria RDT on clinical decisions. METHODS:
Randomized, multi-centre, open clinical trial in two arms in
2006 at the end of the dry and of the rainy season in 10
peripheral health centres in Burkina Faso: one arm with use of
RDT before treatment decision, one arm managed clinically.
Primary endpoint: persistence of fever at day 4. Secondary
endpoints: frequency of malaria treatment and of antibiotic
treatment. RESULTS: A total of 852 febrile patients were
recruited in the dry season and 1317 febrile patients in the
rainy season, and randomized either to be submitted to RDT
(P_RTD) or to be managed presumptively (P_CLIN). In both
seasons, no significant difference was found between the two
randomized groups in the frequency of antimalarial treatment,
nor of antibiotic prescription. In the dry season, 80.8% and
79.8% of patients with a negative RDT were nevertheless
diagnosed and treated for malaria, and so were 85.0% and 82.6%
negative patients in the rainy season. In the rainy season only,
both diagnosis and treatment of other conditions were
significantly less frequent in RDT positive vs. negative patients (48.3% vs. 61.4% and 46.2% vs. 59.9 |