@article{Ruizendaal2017-lk,

title = {Presence of quintuple dhfr N51, C59, S108 - dhps A437, K540  mutations in Plasmodium falciparum isolates from pregnant women  and the general population in Nanoro, Burkina Faso},

author = {Esm\'{e}e Ruizendaal and Marc C Tahita and Maminata Traor\'{e}-Coulibaly and Halidou Tinto and Henk D F H Schallig and Petra F Mens},

doi = {10.1016/j.molbiopara.2017.08.003},

year  = {2017},

date = {2017-10-01},

urldate = {2017-10-01},

journal = {Mol. Biochem. Parasitol.},

volume = {217},

pages = {13--15},

abstract = {Sulphadoxine-pyrimethamine (SP) is only used for intermittent 

 preventive treatment during pregnancy (IPTp) in most Sub-Saharan 

 African countries. However, there are concerns about the efficacy 

 of IPTp-SP because of increasing resistance. Combinations of 

 point mutations in the dhps and dhfr genes of Plasmodium 

 falciparum are associated with SP resistance, in particular the 

 quintuple dhfr (N51, C59, S108) - dhps (codons A437, K540) 

 mutant. In Nanoro, Burkina Faso, filter paper samples from 

 pregnant women at first antenatal care visit and at delivery plus 

 samples from the general population (GP) were studied for dhfr 

 and dhps mutations by sequencing. Quintuple mutants were present 

 in 2 delivery and 4 GP samples. This is the first time the 

 quintuple mutation is found in Burkina Faso and although the 

 prevalence is still very low, emergence of the quintuple mutation 

 could highly diminish the efficacy of IPTp-SP. Close surveillance 

 of SP resistance mutations is therefore warranted.},

keywords = {Intermittent preventive treatment; Plasmodium falciparum;   Pregnancy; Resistance; Sulphadoxine-pyrimethamine},

pubstate = {published},

tppubtype = {article}

}

@article{Ruizendaal2017-mi,

title = {Evaluation of malaria screening during pregnancy with rapid  diagnostic tests performed by community health workers in Burkina  Faso},

author = {Esm\'{e}e Ruizendaal and Henk D F H Schallig and Susana Scott and Maminata Traore-Coulibaly and John Bradley and Palpouguini Lompo and Hamtandi M Natama and Ousmane Traore and Innocent Valea and Susan Dierickx and Koin\'{e} M Drabo and Franco Pagnoni and Umberto d' Alessandro and Halidou Tinto and Petra F Mens},

doi = {10.4269/ajtmh.17-0138},

issn = {1476-1645 0002-9637},

year  = {2017},

date = {2017-10-01},

urldate = {2017-10-01},

journal = {Am. J. Trop. Med. Hyg.},

volume = {97},

number = {4},

pages = {1190--1197},

abstract = {One of the current strategies to prevent malaria in pregnancy is 

 intermittent preventive treatment with sulfadoxine-pyrimethamine 

 (IPTp-SP). However, in order for pregnant women to receive an 

 adequate number of SP doses, they should attend a health facility 

 on a regular basis. In addition, SP resistance may decrease 

 IPTp-SP efficacy. New or additional interventions for preventing 

 malaria during pregnancy are therefore warranted. Because it is 

 known that community health workers (CHWs) can diagnose and treat 

 malaria in children, in this study screening and treatment of 

 malaria in pregnancy by CHWs was evaluated as an addition to the 

 regular IPTp-SP program. CHWs used rapid diagnostic tests (RDTs) 

 for screening and artemether-lumefantrine was given in case of a 

 positive RDT. Overall, CHWs were able to conduct RDTs with a 

 sensitivity of 81.5% (95% confidence interval [CI] 67.9-90.2) 

 and high specificity of 92.1% (95% CI 89.9-93.9) compared with 

 microscopy. After a positive RDT, 79.1% of women received 

 artemether-lumefantrine. When treatment was not given, this was 

 largely due to the woman being already under treatment. Almost 

 all treated women finished the full course of 

 artemether-lumefantrine (96.4%). In conclusion, CHWs are capable 

 of performing RDTs with high specificity and acceptable 

 sensitivity, the latter being dependent on the limit of detection 

 of RDTs. Furthermore, CHWs showed excellent adherence to test 

 results and treatment guidelines, suggesting they can be deployed 

 for screen and treat approaches of malaria in pregnancy.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Schallig2017-ux,

title = {Randomised controlled trial of two sequential artemisinin-based  combination therapy regimens to treat uncomplicated falciparum  malaria in African children: a protocol to investigate safety,  efficacy and adherence},

author = {Henk Dfh Schallig and Halidou Tinto and Patrick Sawa and Harparkash Kaur and Stephan Duparc and Deus S Ishengoma and Pascal Magnussen and Michael Alifrangis and Colin J Sutherland},

doi = {10.1136/bmjgh-2017-000371},

issn = {2059-7908},

year  = {2017},

date = {2017-08-01},

urldate = {2017-08-01},

journal = {BMJ Glob. Health},

volume = {2},

number = {3},

pages = {e000371},

abstract = {BACKGROUND: Management of uncomplicated Plasmodium falciparum 

 malaria relies on artemisinin-based combination therapies (ACTs). 

 These highly effective regimens have contributed to reductions in 

 malaria morbidity and mortality. However, artemisinin resistance 

 in Asia and changing parasite susceptibility to ACT in Africa 

 have now been well documented. Strategies that retain current ACT 

 as efficacious treatments are urgently needed. METHODS: We 

 present an open-label, randomised three-arm clinical trial 

 protocol in three African settings representative of varying 

 malaria epidemiology to investigate whether prolonged ACT-based 

 regimens using currently available formulations can eliminate 

 potentially resistant parasites. The protocol investigates 

 whether a sequential course of two licensed ACT in 1080 children 

 aged 6-120 months exhibits superior efficacy against acute P. 

 falciparum malaria and non-inferior safety compared with standard 

 single-course ACT given to 540 children. The primary endpoint is 

 PCR-corrected clinical and parasitological response at day 42 or 

 day 63 of follow-up. Persistence of PCR-detectable parasitaemia 

 at day 3 is analysed as a key covariate. Secondary endpoints 

 include gametocytaemia, occurrence of treatment-related adverse 

 events in the double-ACT versus single-ACT arms, carriage of 

 molecular markers of drug resistance, drug kinetics and patient 

 adherence to treatment. DISCUSSION: This protocol addresses 

 efficacy and safety of sequential ACT regimens in P. falciparum 

 malaria in Africa. The approach is designed to extend the useful 

 life of this class of antimalarials with maximal impact and 

 minimal delay, by deploying licensed medicines that could be 

 swiftly implemented as sequential double ACT by National Malaria 

 Control Programmes, before emerging drug resistance in Africa 

 becomes a major threat to public health.},

keywords = {malaria; randomised control trial},

pubstate = {published},

tppubtype = {article}

}

@article{Cates2017-vh,

title = {Malaria, malnutrition, and birthweight: A meta-analysis using  individual participant data},

author = {Jordan E Cates and Holger W Unger and Valerie Briand and Nadine Fievet and Innocent Valea and Halidou Tinto and Umberto D'Alessandro and Sarah H Landis and Seth Adu-Afarwuah and Kathryn G Dewey and Feiko O Ter Kuile and Meghna Desai and Stephanie Dellicour and Peter Ouma and Julie Gutman and Martina Oneko and Laurence Slutsker and Dianne J Terlouw and Simon Kariuki and John Ayisi and Mwayiwawo Madanitsa and Victor Mwapasa and Per Ashorn and Kenneth Maleta and Ivo Mueller and Danielle Stanisic and Christentze Schmiegelow and John P A Lusingu and Anna Maria Eijk and Melissa Bauserman and Linda Adair and Stephen R Cole and Daniel Westreich and Steven Meshnick and Stephen Rogerson},

doi = {10.1371/journal.pmed.1002373},

issn = {1549-1676 1549-1277},

year  = {2017},

date = {2017-08-01},

urldate = {2017-08-01},

journal = {PLoS Med.},

volume = {14},

number = {8},

pages = {e1002373},

abstract = {BACKGROUND: Four studies previously indicated that the effect of 

 malaria infection during pregnancy on the risk of low birthweight 

 (LBW; \<2,500 g) may depend upon maternal nutritional status. We 

 investigated this dependence further using a large, diverse study 

 population. METHODS AND FINDINGS: We evaluated the interaction 

 between maternal malaria infection and maternal anthropometric 

 status on the risk of LBW using pooled data from 14,633 

 pregnancies from 13 studies (6 cohort studies and 7 randomized 

 controlled trials) conducted in Africa and the Western Pacific 

 from 1996-2015. Studies were identified by the Maternal Malaria 

 and Malnutrition (M3) initiative using a convenience sampling 

 approach and were eligible for pooling given adequate ethical 

 approval and availability of essential variables. Study-specific 

 adjusted effect estimates were calculated using inverse 

 probability of treatment-weighted linear and log-binomial 

 regression models and pooled using a random-effects model. The 

 adjusted risk of delivering a baby with LBW was 8.8% among women 

 with malaria infection at antenatal enrollment compared to 7.7% 

 among uninfected women (adjusted risk ratio [aRR] 1.14 [95% confidence interval (CI): 0.91, 1.42]; N = 13,613), 10.5% among 

 women with malaria infection at delivery compared to 7.9% among uninfected women (aRR 1.32 [95% CI: 1.08, 1.62]; N = 11,826), 

 and 15.3% among women with low mid-upper arm circumference (MUAC 

 \<23 cm) at enrollment compared to 9.5% among women with MUAC $geq$ 23 cm (aRR 1.60 [95% CI: 1.36, 1.87]; N = 9,008). The 

 risk of delivering a baby with LBW was 17.8% among women with 

 both malaria infection and low MUAC at enrollment compared to 

 8.4% among uninfected women with MUAC $geq$ 23 cm (joint aRR 2.13 [95% CI: 1.21, 3.73]; N = 8,152). There was no evidence of 

 synergism (i.e., excess risk due to interaction) between malaria infection and MUAC on the multiplicative (p = 0.5) or additive scale (p = 0.9). Results were similar using body mass index (BMI) 

 as an anthropometric indicator of nutritional status. 

 Meta-regression results indicated that there may be 

 multiplicative interaction between malaria infection at 

 enrollment and low MUAC within studies conducted in Africa; 

 however, this finding was not consistent on the additive scale, 

 when accounting for multiple comparisons, or when using other 

 definitions of malaria and malnutrition. The major limitations of 

 the study included availability of only 2 cross-sectional 

 measurements of malaria and the limited availability of 

 ultrasound-based pregnancy dating to assess impacts on preterm 

 birth and fetal growth in all studies. CONCLUSIONS: Pregnant 

 women with malnutrition and malaria infection are at increased 

 risk of LBW compared to women with only 1 risk factor or none, 

 but malaria and malnutrition do not act synergistically.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Decuypere2017-io,

title = {Correction: Diagnosis of bacterial bloodstream infections: A  16S metagenomics approach},

author = {Saskia Decuypere and Conor J Meehan and Sandra Van Puyvelde and Tessa De Block and Jessica Maltha and Lompo Palpouguini and Marc Tahita and Halidou Tinto and Jan Jacobs and Stijn Deborggraeve},

doi = {10.1371/journal.pntd.0005811},

issn = {1935-2735 1935-2727},

year  = {2017},

date = {2017-07-01},

urldate = {2017-07-01},

journal = {PLoS Negl. Trop. Dis.},

volume = {11},

number = {7},

pages = {e0005811},

publisher = {Public Library of Science (PLoS)},

abstract = {[This corrects the article DOI: 10.1371/journal.pntd.0004470.].},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Kiemde2017-el,

title = {Accuracy of a Plasmodium falciparum specific histidine-rich  protein 2 rapid diagnostic test in the context of the presence of  non-malaria fevers, prior anti-malarial use and seasonal malaria  transmission},

author = {Francois Kiemde and Massa Dit Achille Bonko and Marc Christian Tahita and Palpouguini Lompo and Toussaint Rouamba and Halidou Tinto and Michael Boele Hensbroek and Petra F Mens and Henk D F H Schallig},

doi = {10.1186/s12936-017-1941-6},

issn = {1475-2875},

year  = {2017},

date = {2017-07-01},

urldate = {2017-07-01},

journal = {Malar. J.},

volume = {16},

number = {1},

pages = {294},

abstract = {BACKGROUND: It remains challenging to distinguish malaria from 

 other fever causing infections, as a positive rapid diagnostic 

 test does not always signify a true active malaria infection. 

 This study was designed to determine the influence of other 

 causes of fever, prior anti-malarial treatment, and a possible 

 seasonality of the performance of a PfHRP2 RDT for the diagnosis 

 of malaria in children under-5 years of age living in a malaria 

 endemic area. METHODS: A prospective etiology study was conducted 

 in 2015 among febrile children under 5 years of age in Burkina 

 Faso. In order to assess the influence of other febrile 

 illnesses, prior treatment and seasonality on the performance of 

 a PfHRP2 RDT in diagnosing malaria, the RDT results were compared 

 with the gold standard (expert microscopic diagnosis of 

 Plasmodium falciparum) and test results were analysed by assuming 

 that prior anti-malarial use and bacterial/viral infection status 

 would have been known prior to testing. To assess bacterial and 

 viral infection status blood, urine and stool samples were 

 analysed. RESULTS: In total 683 blood samples were analysed with 

 microscopy and RDT-PfHRP2. Plasmodium falciparum malaria was 

 diagnosed in 49.8% (340/683) by microscopy compared to 69.5% 

 (475/683) by RDT-PfHRP2. The RDT-PfHRP2 reported 29.7% (141/475) 

 false positive results and 1.8% (6/340) false negative cases. 

 The RDT-PfHRP2 had a high sensitivity (98.2%) and negative 

 predictive value (97.1%), but a low specificity (58.9%) and 

 positive predictive value (70.3%). Almost 50% of the 

 alternative cause of fever were diagnosed by laboratory testing 

 in the RDT false positive malaria group. CONCLUSIONS: The use of 

 a malaria RDT-PfHRP2 in a malaria endemic area may cause 

 misdiagnosis of the actual cause of fever due to false positive 

 test results. The development of a practical diagnostic tool to 

 screen for other causes of fever in malaria endemic areas is 

 required to save lives.},

keywords = {Accuracy; Diagnosis; Fever; Malaria; RDT-PfHRP2; Sensitivity;   Specificity},

pubstate = {published},

tppubtype = {article}

}

@article{Guiraud2017-sh,

title = {Population-based incidence, seasonality and serotype  distribution of invasive salmonellosis among children in Nanoro,  rural Burkina Faso},

author = {Issa Guiraud and Annelies Post and Seydou Nakanabo Diallo and Palpouguini Lompo and Jessica Maltha and Kamala Thriemer and Christian Marc Tahita and Benedikt Ley and Karim Derra and Emmanuel Bottieau and Adama Kazienga and C\'{e}line Schurmans and Raffaella Ravinetto and Eli Rouamba and Johan Van Griensven and Sophie Bertrand and Halidou Tinto and Jan Jacobs},

doi = {10.1371/journal.pone.0178577},

issn = {1932-6203},

year  = {2017},

date = {2017-07-01},

urldate = {2017-07-01},

journal = {PLoS One},

volume = {12},

number = {7},

pages = {e0178577},

publisher = {Public Library of Science (PLoS)},

abstract = {BACKGROUND: Bloodstream infections (BSI) caused by Salmonella 

 Typhi and invasive non-Typhoidal Salmonella (iNTS) frequently 

 affect children living in rural sub-Saharan Africa but data 

 about incidence and serotype distribution are rare. OBJECTIVE: 

 The present study assessed the population-based incidence of 

 Salmonella BSI and severe malaria in a Health and Demographic 

 Surveillance System in a rural area with seasonal malaria 

 transmission in Nanoro, Burkina Faso. METHODS: Children between 

 2 months-15 years old with severe febrile illness were enrolled 

 during a one-year surveillance period (May 2013-May 2014). Thick 

 blood films and blood cultures were sampled and processed upon 

 admission. Population-based incidences were corrected for 

 non-referral, health seeking behavior, non-inclusion and blood 

 culture sensitivity. Adjusted incidence rates were expressed per 

 100,000 person-years of observations (PYO). RESULTS: Among 

 children \< 5 years old, incidence rates for iNTS, Salmonella 

 Typhi and severe malaria per 100,000 PYO were 4,138 (95% 

 Confidence Interval (CI): 3,740-4,572), 224 (95% CI: 138-340) 

 and 2,866 (95% CI: 2,538-3,233) respectively. Among those aged 

 5-15 years, corresponding incidence rates were 25 (95% CI: 

 8-60), 273 (95% CI: 203-355) and 135 (95% CI: 87-195) 

 respectively. Most iNTS occurred during the peak of the rainy 

 season and in parallel with the increase of Plasmodium 

 falciparum malaria; for Salmonella Typhi no clear seasonal 

 pattern was observed. Salmonella Typhi and iNTS accounted for 

 13.3% and 55.8% of all 118 BSI episodes; 71.6% of iNTS 

 (48/67) isolates were Salmonella enterica serovar Typhimurium 

 and 25.4% (17/67) Salmonella enterica serovar Enteritidis; 

 there was no apparent geographical clustering. CONCLUSION: The 

 present findings from rural West-Africa confirm high incidences 

 of Salmonella Typhi and iNTS, the latter with a seasonal and 

 Plasmodium falciparum-related pattern. It urges prioritization 

 of the development and implementation of Salmonella Typhi as 

 well as iNTS vaccines in this setting.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Gomez-Olive2017-jn,

title = {Regional and sex differences in the prevalence and awareness of  hypertension: An H3Africa AWI-gen study across 6 sites in  sub-Saharan Africa},

author = {F Xavier G\'{o}mez-Oliv\'{e} and Stuart A Ali and Felix Made and Catherine Kyobutungi and Engelbert Nonterah and Lisa Micklesfield and Marianne Alberts and Romuald Boua and Scott Hazelhurst and Cornelius Debpuur and Felistas Mashinya and Sekgothe Dikotope and Hermann Sorgho and Ian Cook and Stella Muthuri and Cassandra Soo and Freedom Mukomana and Godfred Agongo and Christopher Wandabwa and Sulaimon Afolabi and Abraham Oduro and Halidou Tinto and Ryan G Wagner and Tilahun Haregu and Alisha Wade and Kathleen Kahn and Shane A Norris and Nigel J Crowther and Stephen Tollman and Osman Sankoh and Mich`ele Ramsay and AWI-Gen and H3Africa Consortium},

doi = {10.1016/j.gheart.2017.01.007},

issn = {2211-8179 },

year  = {2017},

date = {2017-06-01},

urldate = {2017-06-01},

journal = {Glob. Heart},

volume = {12},

number = {2},

pages = {81--90},

abstract = {BACKGROUND: There is a high prevalence of hypertension and 

 related cardiovascular diseases in sub-Saharan Africa, yet few 

 large studies exploring hypertension in Africa are available. The 

 actual burden of disease is poorly understood and awareness and 

 treatment to control it is often suboptimal. OBJECTIVES: The 

 study sought to report the prevalence of measured hypertension 

 and to assess awareness and control of blood pressure among older 

 adults in rural and urban settings in 6 sites located in West, 

 East, and Southern Africa. In addition, we examined regional, 

 sex, and age differences related to hypertension. METHODS: A 

 population-based cross-sectional study was performed at 6 sites 

 in 4 African countries: Burkina Faso (Nanoro), Ghana (Navrongo), 

 Kenya (Nairobi), and South Africa (Agincourt, Dikgale, Soweto). 

 Blood pressure measurements were taken using standardized 

 procedures on 10,696 adults 40 to 60 years of age. Hypertension 

 was defined as systolic blood pressure $geq$140 mm Hg or 

 diastolic blood pressure $geq$90 mm Hg or taking 

 antihypertensive medication. RESULTS: The mean prevalence of 

 hypertension ranged from 15.1% in Nanoro to 54.1% in Soweto. 

 All 3 of the South African sites had a mean prevalence of 

 hypertension of over 40.0%, significantly higher than in Nairobi 

 (25.6%) and Navrongo (24.5%). Prevalence increased with age in 

 both sexes and at all sites. A significantly higher prevalence of 

 hypertension was observed in women in Agincourt, Dikgale, and 

 Nairobi, whereas in Nanoro this trend was reversed. Within the 

 hypertensive group the average proportion of participants who 

 were aware of their blood pressure status was only 39.4% for men 

 and 53.8% for women, and varied widely across sites. 

 CONCLUSIONS: Our study demonstrates that the prevalence of 

 hypertension and the level of disease awareness differ not only 

 between but also within sub-Saharan African countries. Each 

 nation must tailor their regional hypertension awareness and 

 screening programs to match the characteristics of their local 

 populations.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Natama2017-ep,

title = {Diagnosing congenital malaria in a high-transmission setting:  clinical relevance and usefulness of P. falciparum HRP2-based  testing},

author = {Hamtandi Magloire Natama and Delwend\'{e} Florence Ouedraogo and Hermann Sorgho and Eduard Rovira-Vallbona and Elisa Serra-Casas and M Athanase Som\'{e} and Maminata Coulibaly-Traor\'{e} and Petra F Mens and Luc Kestens and Halidou Tinto and Anna Rosanas-Urgell},

doi = {10.1038/s41598-017-02173-6},

issn = {2045-2322},

year  = {2017},

date = {2017-05-01},

urldate = {2017-05-01},

journal = {Sci. Rep.},

volume = {7},

number = {1},

pages = {2080},

publisher = {Springer Science and Business Media LLC},

abstract = {Congenital malaria diagnosis is challenging due to frequently 

 observed low parasite density infections, while their clinical 

 relevance during early infancy is not well characterized. In 

 Nanoro health district (Burkina Faso), we determined the 

 prevalence of congenital malaria by real-time quantitative PCR 

 and we assessed the performance of rapid diagnosis test (RDT) 

 and light microscopy (LM) to detect Plasmodium falciparum 

 infections in cord-blood samples. In addition, we examined the 

 usefulness of P. falciparum Histidine Rich Protein2 (PfHRP2) as 

 surrogate biomarker of infection and explored association 

 between congenital malaria and clinical outcomes. A prevalence 

 of congenital malaria by qPCR of 4% (16/400) was found, which 

 increased to 10% among newborns from mothers infected at 

 delivery. RDT and LM showed poor performances indicating limited 

 utility for congenital malaria screening in cord blood. Because 

 PfHRP2 detection in cord blood could be affected by 

 transplacental passage of parasite antigens, PfHRP2 might not be 

 used as a surrogate biomarker of congenital malaria infections. 

 There was no evidence of a significant clinical impact of 

 congenital malaria on infant's health from birth to 59 days of 

 life. Case control studies including long-term follow up may 

 provide additional understanding on the relevance of neonatal 

 malaria infections.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Held2017-eo,

title = {Safety and efficacy of the choline analogue SAR97276 for  malaria treatment: results of two phase 2, open-label,  multicenter trials in African patients},

author = {Jana Held and Christian Supan and Carmen L Ospina Salazar and Halidou Tinto and L\'{e}a Nad`ege Bonkian and Alain Nahum and Ali Si\'{e} and Salim Abdulla and Cathy Cantalloube and Elhadj Djeriou and Marielle Bouyou-Akotet and Bernhards Ogutu and Benjamin Mordm\"{u}ller and Andrea Kreidenweiss and Mohamadou Siribie and Sodiomon B Sirima and Peter G Kremsner},

doi = {10.1186/s12936-017-1832-x},

issn = {1475-2875},

year  = {2017},

date = {2017-05-01},

urldate = {2017-05-01},

journal = {Malar. J.},

volume = {16},

number = {1},

pages = {188},

abstract = {BACKGROUND: Malaria remains one of the most important infectious 

 diseases. Treatment options for severe malaria are limited and 

 the choline analogue SAR97276A is a novel chemical entity that 

 was developed primarily as treatment for severe malaria. Before 

 starting clinical investigations in severely ill malaria 

 patients, safety and efficacy of SAR97276A was studied in 

 patients with uncomplicated malaria. Here, we summarize two 

 open-label, multi-center phase 2 trials assessing safety and 

 efficacy of parenterally administered SAR97276A in African adults 

 and children with falciparum malaria. RESULTS: Study 1 was 

 conducted in Burkina Faso, Gabon, Benin and Tanzania between 

 August 2008 and July 2009 in malaria patients in an age 

 de-escalating design (adults, children). A total of 113 malaria 

 patients received SAR97276A. Adults were randomized to receive a 

 single dose SAR97296A given either intramuscularly (IM) (0.18 

 mg/kg) or intravenously (IV) (0.14 mg/kg). If a single dose was 

 not efficacious a second adult group was planned to test a three 

 dose regimen administered IM once daily for 3 days. Single dose 

 SAR97276A showed insufficient efficacy in adults (IM: 20 of 34 

 cured, 59%; and IV: 23/30 cured, 77%). The 3-day IM regimen 

 showed acceptable efficacy in adults (27/30, 90%) but not in 

 children (13/19, 68%). SAR97276A was well tolerated but no 

 further groups were recruited due lack of efficacy. Study 2 was 

 conducted between October 2011 and January 2012 in Burkina Faso, 

 Gabon and Kenya. SAR97276A administered at a higher dose given IM 

 was compared to artemether-lumefantrine. The study population was 

 restricted to underage malaria patients to be subsequently 

 enrolled in two age cohorts (teenagers, children). Rescue therapy 

 was required in all teenaged malaria patients (8/8) receiving 

 SAR97276A once daily (0.5 mg/kg) for 3 days and in 5 out of 8 

 teenaged patients treated twice daily (0.25 mg/kg) for 3 days. 

 All patients (4/4) in the control group were cured. The study was 

 stopped, before enrollment of children, due to lack of efficacy 

 but the overall safety profile was good. CONCLUSIONS: Monotherapy 

 with SAR97276A up to twice daily for 3 days is not an efficacious 

 treatment for falciparum malaria. SAR97276A will not be further 

 developed for the treatment of malaria. Trial registration at 

 clinicaltrials.gov: NCT00739206, retrospectively registered 

 August 20, 2008 for Study 1 and NCT01445938 registered September 

 26, 2011 for Study 2.},

keywords = {Africa; Choline analogue; Malaria; P. falciparum; Phase 2;   SAR97276A},

pubstate = {published},

tppubtype = {article}

}

@article{Greenwood2017-is,

title = {Seasonal vaccination against malaria: a potential use for an  imperfect malaria vaccine},

author = {Brian Greenwood and Alassane Dicko and Issaka Sagara and Issaka Zongo and Halidou Tinto and Matthew Cairns and Irene Kuepfer and Paul Milligan and Jean-Bosco Ouedraogo and Ogobara Doumbo and Daniel Chandramohan},

doi = {10.1186/s12936-017-1841-9},

issn = {1475-2875},

year  = {2017},

date = {2017-05-01},

urldate = {2017-05-01},

journal = {Malar. J.},

volume = {16},

number = {1},

pages = {182},

abstract = {In many parts of the African Sahel and sub-Sahel, where malaria 

 remains a major cause of mortality and morbidity, transmission of 

 the infection is highly seasonal. Seasonal malaria 

 chemoprevention (SMC), which involves administration of a full 

 course of malaria treatment to young children at monthly 

 intervals during the high transmission season, is proving to be 

 an effective malaria control measure in these areas. However, SMC 

 does not provide complete protection and it is demanding to 

 deliver for both families and healthcare givers. Furthermore, 

 there is a risk of the emergence in the future of resistance to 

 the drugs, sulfadoxine-pyrimethamine and amodiaquine, that are 

 currently being used for SMC. Substantial progress has been made 

 in the development of malaria vaccines during the past decade and 

 one malaria vaccine, RTS,S/AS01, has received a positive opinion 

 from the European Medicines Authority and will soon be deployed 

 in large-scale, pilot implementation projects in sub-Saharan 

 Africa. A characteristic feature of this vaccine, and potentially 

 of some of the other malaria vaccines under development, is that 

 they provide a high level of efficacy during the period 

 immediately after vaccination, but that this wanes rapidly, 

 perhaps because it is difficult to develop effective 

 immunological memory to malaria antigens in subjects exposed 

 previously to malaria infection. A potentially effective way of 

 using malaria vaccines with high initial efficacy but which 

 provide only a short period of protection could be annual, mass 

 vaccination campaigns shortly before each malaria transmission 

 season in areas where malaria transmission is confined largely to 

 a few months of the year.},

keywords = {Seasonal malaria chemoprevention; Seasonal malaria transmission;   Seasonal malaria vaccination},

pubstate = {published},

tppubtype = {article}

}

@article{Dellicour2017-rh,

title = {First-trimester artemisinin derivatives and quinine treatments  and the risk of adverse pregnancy outcomes in Africa and Asia: A  meta-analysis of observational studies},

author = {Stephanie Dellicour and Esperanc ca Sevene and Rose McGready and Halidou Tinto and Dominic Mosha and Christine Manyando and Stephen Rulisa and Meghna Desai and Peter Ouma and Martina Oneko and Anifa Vala and Maria Rup\'{e}rez and Eus\'{e}bio Macete and Clara Men\'{e}ndez and Seydou Nakanabo-Diallo and Adama Kazienga and Innocent Val\'{e}a and Gregory Calip and Orvalho Augusto and Blaise Genton and Eric M Njunju and Kerryn A Moore and Umberto d'Alessandro and Francois Nosten and Feiko Ter Kuile and Andy Stergachis},

doi = {10.1371/journal.pmed.1002290},

issn = {1549-1676 1549-1277},

year  = {2017},

date = {2017-05-01},

urldate = {2017-05-01},

journal = {PLoS Med.},

volume = {14},

number = {5},

pages = {e1002290},

abstract = {BACKGROUND: Animal embryotoxicity data, and the scarcity of 

 safety data in human pregnancies, have prevented artemisinin 

 derivatives from being recommended for malaria treatment in the 

 first trimester except in lifesaving circumstances. We conducted 

 a meta-analysis of prospective observational studies comparing 

 the risk of miscarriage, stillbirth, and major congenital anomaly 

 (primary outcomes) among first-trimester pregnancies treated with 

 artemisinin derivatives versus quinine or no antimalarial 

 treatment. METHODS AND FINDINGS: Electronic databases including 

 Medline, Embase, and Malaria in Pregnancy Library were searched, 

 and investigators contacted. Five studies involving 30,618 pregnancies were included; four from sub-Saharan Africa (n = 6,666 pregnancies, six sites) and one from Thailand (n = 23,952). 

 Antimalarial exposures were ascertained by self-report or active 

 detection and confirmed by prescriptions, clinic cards, and 

 outpatient registers. Cox proportional hazards models, accounting 

 for time under observation and gestational age at enrollment, 

 were used to calculate hazard ratios. Individual participant data 

 (IPD) meta-analysis was used to combine the African studies, and 

 the results were then combined with those from Thailand using 

 aggregated data meta-analysis with a random effects model. There 

 was no difference in the risk of miscarriage associated with the use of artemisinins anytime during the first trimester (n = 37/671) compared with quinine (n = 96/945; adjusted hazard ratio [aHR] = 0.73 [95% CI 0.44, 1.21},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Ruizendaal2017-zh,

title = {Increase in the prevalence of mutations associated with  sulfadoxine-pyrimethamine resistance in Plasmodium falciparum  isolates collected from early to late pregnancy in Nanoro,  Burkina Faso},

author = {Esm\'{e}e Ruizendaal and Marc C Tahita and Ronald B Geskus and Inge Versteeg and Susana Scott and Umberto d'Alessandro and Palpouguini Lompo and Karim Derra and Maminata Traore-Coulibaly and Menno D Jong and Henk D F H Schallig and Halidou Tinto and Petra F Mens},

doi = {10.1186/s12936-017-1831-y},

issn = {1475-2875},

year  = {2017},

date = {2017-04-01},

urldate = {2017-04-01},

journal = {Malar. J.},

volume = {16},

number = {1},

pages = {179},

abstract = {BACKGROUND: Pregnant women are a high-risk group for Plasmodium 

 falciparum infections, which may result in maternal anaemia and 

 low birth weight newborns, among other adverse birth outcomes. 

 Intermittent preventive treatment with sulfadoxine-pyrimethamine 

 during pregnancy (IPTp-SP) is widely implemented to prevent these 

 negative effects of malaria. However, resistance against SP by P. 

 falciparum may decrease efficacy of IPTp-SP. Combinations of 

 point mutations in the dhps (codons A437, K540) and dhfr genes 

 (codons N51, C59, S108) of P. falciparum are associated with SP 

 resistance. In this study the prevalence of SP resistance 

 mutations was determined among P. falciparum found in pregnant 

 women and the general population (GP) from Nanoro, Burkina Faso 

 and the association of IPTp-SP dosing and other variables with 

 mutations was studied. METHODS: Blood spots on filter papers were 

 collected from pregnant women at their first antenatal care visit 

 (ANC booking) and at delivery, from an ongoing trial and from the 

 GP in a cross-sectional survey. The dhps and dhfr genes were 

 amplified by nested PCR and products were sequenced to identify mutations conferring resistance (ANC bookin},

keywords = {Mutations; Plasmodium falciparum; Pregnancy; Resistance;   Sulfadoxine-pyrimethamine},

pubstate = {published},

tppubtype = {article}

}

@article{Cisse2017-td,

title = {Recent uptake of intermittent preventive treatment during  pregnancy with sulfadoxine-pyrimethamine is associated with  increased prevalence of Pfdhfr mutations in Bobo-Dioulasso, Burkina Faso},

author = {Mamoudou Cisse and Gordon A Awandare and Alamissa Soulama and Halidou Tinto and Marie-Pierre Hayette and Robert T Guiguemd\'{e}},

doi = {10.1186/s12936-017-1695-1},

issn = {1475-2875},

year  = {2017},

date = {2017-01-01},

urldate = {2017-01-01},

journal = {Malar. J.},

volume = {16},

number = {1},

pages = {38},

abstract = {BACKGROUND: The impact of sulfadoxine-pyrimethamine (SP) used as 

 intermittent preventive treatment during pregnancy (IPTp-SP) on 

 mutant parasite selection has been poorly documented in Burkina 

 Faso. This study sought first to explore the relationship between 

 IPTp-SP and the presence of mutant parasites. Second, to assess 

 the relationship between the mutant parasites and adverse 

 pregnancy outcomes. METHODS: From September to December 2010, 

 dried blood spots (DBS) were collected during antenatal care 

 visits and at delivery from 109 pregnant women with 

 microscopically confirmed falciparum malaria infection. DBS were 

 analysed by PCR-restriction fragment length polymorphism 

 (PCR-RFLP) for the polymorphisms at codons 51, 59, 108, and 164 

 of the Pfdhfr gene and codons 437 and 540 in the Pfdhps gene. 

 RESULTS: Both the Pfdhfr and Pfdhps genes were successfully 

 genotyped in 92.7% (101/109) of the samples. The prevalence of 

 Pfdhfr mutations N51I, C59R and S108N was 71.3, 42.6 and 64.4%, 

 respectively. Overall, 80.2% (81/101) of samples carried the 

 Pfdhps A437G mutation. None of the samples had the Pfdhfr I164L 

 and the Pfdhps K540E mutations. The prevalence of the triple 

 mutation N51I + C59R + S108N was 25.7% (26/101). The use of 

 IPTp-SP was associated with a threefold increased odds of Pfdhfr 

 C59R mutation [crude OR 3.29; 95% CI (1.44-7.50)]. Pregnant 

 women with recent uptake of IPTp-SP were at higher odds of both 

 the Pfdhfr C59R mutation [adjusted OR 4.26; 95% CI (1.64-11.07)] 

 and the Pfdhfr intermediate-to-high resistance, i.e., $geq$ 2 

 Pfdhfr mutations [adjusted OR 3.45; 95% CI (1.18-10.07)]. There 

 was no statistically significant association between the presence 

 of the Pfdhfr intermediate-to-high resistance and parasite 

 densities or both maternal haemoglobin level and anaemia. 

 CONCLUSION: The data indicate that despite the possibility that 

 IPTp-SP contributes to the selection of resistant parasites, it 

 did not potentiate pregnancy-associated malaria morbidity, 

 suggesting the continuation of SP use as IPTp in Burkina Faso.},

keywords = {Burkina Faso; Drug resistance; Malaria; Pregnancy;   Sulfadoxine-pyrimethamine},

pubstate = {published},

tppubtype = {article}

}

@article{Sondo2017-pu,

title = {Comparison of effectiveness of two different artemisinin-based  combination therapies in an area with high seasonal transmission  of malaria in Burkina Faso},

author = {Paul Sondo and Karim Derra and Seydou Diallo Nakanabo and Zekiba Tarnagda and Adama Kazienga and Innocent Valea and Herman Sorgho and Jean-Bosco Ou\'{e}draogo and Tinga Robert Guiguemd\'{e} and Halidou Tinto},

doi = {10.17420/ap6302.96},

issn = {2299-0631},

year  = {2017},

date = {2017-01-01},

urldate = {2017-01-01},

journal = {Ann. Parasitol.},

volume = {63},

number = {2},

pages = {127--131},

abstract = {In Sahelian countries such as Burkina Faso, malaria transmission 

 is seasonal with a high incidence of transmission during the 

 rainy season. This study aimed to compare the effectiveness of 

 the two recommended treatments (Artemether-Lumefantrine and 

 Artesunate-Amodiaquine) for uncomplicated malaria in Burkina Faso 

 regarding this seasonal variation of malaria transmission. This 

 is part of a randomized open label trial comparing the 

 effectiveness and safety of Artemether-Lumefantrine versus 

 Artesunate-Amodiaquine according to routine practice in Nanoro. 

 Patients with uncomplicated falciparum malaria were recruited all 

 year round and followed-up for 28 days. To distinguish 

 recrudescences from new infections, dried blood spots from day 0 

 and day of recurrent parasitaemia were used for nested-PCR 

 genotyping of the polymorphic loci of the merozoite surface 

 proteins 1 and 2. Seasonal influence was investigated by 

 assessing the treatment outcomes according to the recruitment 

 period of the patients. Two main groups (dry season versus rainy 

 season) were defined following the seasonal characteristics of 

 the study area. In Artemether-Lumefantrine group, the uncorrected 

 cure rate was 76.5% in dry season versus 37.9% in rainy season. 

 In Artesunate-Amodiaquine group, this was 93.3% and 57.1% 

 during dry and rainy seasons, respectively. After PCR adjustment, 

 the cure rate decreased from 85.9% in dry season to 75.0% in 

 rainy season in Artemether-Lumefantrine group. InA 

 rtesunate-Amodiaquine group, it was 93.3% in dry season and 

 80.7% during the rainy season. During the rainy season around 

 50% of patients had a new malaria episode by Day 28. The cure 

 rate of both Artemether-Lumefantrine and Artesunate-Amodiaquine 

 treatments was higher in dry season compared to rainy season due 

 to high incidence of reinfections during the rainy season. For 

 this reason, in addition to the curative effect, the 

 post-treatment prophylactic effect should be taken into account 

 in the choice of antimalarial regimens.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Mavoko2017-qv,

title = {Efficacy and safety of re-treatment with the same  artemisinin-based combination treatment (ACT) compared with an  alternative ACT and quinine plus clindamycin after failure of  first-line recommended ACT (QUINACT): a bicentre, open-label,  phase 3, randomised controlled trial},

author = {Hypolite Muhindo Mavoko and Carolyn Nabasumba and Raquel Inoc^encio Luz and Halidou Tinto and Umberto D'Alessandro and Andrew Kambugu and Vito Baraka and Anna Rosanas-Urgell and Pascal Lutumba and Jean-Pierre Van Geertruyden},

doi = {10.1016/S2214-109X(16)30236-4},

issn = {2214-109X},

year  = {2017},

date = {2017-01-01},

urldate = {2017-01-01},

journal = {Lancet Glob. Health},

volume = {5},

number = {1},

pages = {e60--e68},

abstract = {BACKGROUND: Quinine or alternative artemisinin-based combination 

 treatment (ACT) is the recommended rescue treatment for 

 uncomplicated malaria. However, patients are often re-treated 

 with the same ACT though it is unclear whether this is the most 

 suitable approach. We assessed the efficacy and safety of 

 re-treating malaria patients with uncomplicated failures with the 

 same ACT used for the primary episode, compared with other rescue 

 treatments. METHODS: This was a bicentre, open-label, randomised, 

 three-arm phase 3 trial done in Lisungi health centre in DR 

 Congo, and Kazo health centre in Uganda in 2012-14. Children aged 

 12-60 months with recurrent malaria infection after treatment 

 with the first-line ACT were randomly assigned to either 

 re-treatment with the same first-line ACT, an alternative ACT, 

 which were given for 3 days, or quinine-clindamycin (QnC), which 

 was given for 5-7 days, following a 2:2:1 ratio. Randomisation 

 was done by computer-generated randomisation list in a block 

 design by country. The three treatment groups were assumed to 

 have equivalent efficacy above 90%. Both the research team and 

 parents or guardians were aware of treatment allocation. The 

 primary outcome was the proportion of patients with an adequate 

 clinical and parasitological response (ACPR) at day 28, in the 

 per-protocol population. This trial was registered under the 

 numbers NCT01374581 in ClinicalTrials.gov and 

 PACTR201203000351114 in the Pan African Clinical Trials Registry. 

 FINDINGS: From May 22, 2012, to Jan 31, 2014, 571 children were 

 included in the trial. 240 children were randomly assigned to the 

 re-treatment ACT group, 233 to the alternative ACT group, and 98 

 to the QnC group. 500 children were assessed for the primary 

 outcome. 71 others were not included because they did not 

 complete the follow-up or PCR genotyping result was not 

 conclusive. The ACPR response was similar in the three groups: 

 91·4% (95% CI 87·5-95·2) for the re-treatment ACT, 91·3% (95% 

 CI 87·4-95·1) for the alternative ACT, and 89·5% (95% CI 

 83·0-96·0) for QnC. The estimates for rates of malaria 

 recrudescence in the three treatment groups were similar (log-rank test: $chi$2=0·2},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Unger2016-na,

title = {Maternal Malaria and Malnutrition (M3) initiative, a pooled birth 

 cohort of 13 pregnancy studies in Africa and the Western Pacific},

author = {Holger W Unger and Jordan E Cates and Julie Gutman and Valerie Briand and Nadine Fievet and Innocent Valea and Halidou Tinto and Umberto d'Alessandro and Sarah H Landis and Seth Adu-Afarwuah and Kathryn G Dewey and Feiko Ter Kuile and Stephanie Dellicour and Peter Ouma and Laurence Slutsker and Dianne J Terlouw and Simon Kariuki and John Ayisi and Bernard Nahlen and Meghna Desai and Mwayi Madanitsa and Linda Kalilani-Phiri and Per Ashorn and Kenneth Maleta and Ivo Mueller and Danielle Stanisic and Christentze Schmiegelow and John Lusingu and Daniel Westreich and Anna Maria Eijk and Steven Meshnick and Stephen Rogerson},

year  = {2016},

date = {2016-12-01},

journal = {BMJ Open},

volume = {6},

number = {12},

pages = {e012697},

abstract = {PURPOSE: The Maternal Malaria and Malnutrition (M3) initiative 

 has pooled together 13 studies with the hope of improving 

 understanding of malaria-nutrition interactions during pregnancy 

 and to foster collaboration between nutritionists and 

 malariologists. PARTICIPANTS: Data were pooled on 14 635 

 singleton, live birth pregnancies from women who had participated 

 in 1 of 13 pregnancy studies. The 13 studies cover 8 countries in 

 Africa and Papua New Guinea in the Western Pacific conducted from 

 1996 to 2015. FINDINGS TO DATE: Data are available at the time of 

 antenatal enrolment of women into their respective parent study 

 and at delivery. The data set comprises essential data such as 

 malaria infection status, anthropometric assessments of maternal 

 nutritional status, presence of anaemia and birth weight, as well 

 as additional variables such gestational age at delivery for a 

 subset of women. Participating studies are described in detail 

 with regard to setting and primary outcome measures, and 

 summarised data are available from each contributing cohort. 

 FUTURE PLANS: This pooled birth cohort is the largest pregnancy 

 data set to date to permit a more definite evaluation of the 

 impact of plausible interactions between poor nutritional status 

 and malaria infection in pregnant women on fetal growth and 

 gestational length. Given the current comparative lack of large 

 pregnancy cohorts in malaria-endemic settings, compilation of 

 suitable pregnancy cohorts is likely to provide adequate 

 statistical power to assess malaria-nutrition interactions, and 

 could point towards settings where such interactions are most 

 relevant. The M3 cohort may thus help to identify pregnant women 

 at high risk of adverse outcomes who may benefit from tailored 

 intensive antenatal care including nutritional supplements and 

 alternative or intensified malaria prevention regimens, and the 

 settings in which these interventions would be most effective.},

keywords = {malaria; malnutrition; pregnancy},

pubstate = {published},

tppubtype = {article}

}

@article{Kirakoya-Samadoulougou2016-vb,

title = {Using health and demographic surveillance systems for 

 teratovigilance in Africa},

author = {Fati Kirakoya-Samadoulougou and Issiaka Sombi\'{e} and Bernhards Ogutu and Halidou Tinto and Seni Kouanda and Alfred B Tiono and Walter Otieno and Alexander Dodoo and Mamusu Kamanda and Osman Sankoh},

year  = {2016},

date = {2016-12-01},

journal = {Lancet Glob. Health},

volume = {4},

number = {12},

pages = {e906},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Ravinetto2016-uy,

title = {It is time to revise the international Good Clinical Practices 

 guidelines: recommendations from non-commercial North-South 

 collaborative trials},

author = {Raffaella Ravinetto and Halidou Tinto and Ermias Diro and Joseph Okebe and Yodi Mahendradhata and Suman Rijal and Eduardo Gotuzzo and Pascal Lutumba and Alain Nahum and Katelijne De Nys and Minne Casteels and Marleen Boelaert},

year  = {2016},

date = {2016-11-01},

journal = {BMJ Glob. Health},

volume = {1},

number = {3},

pages = {e000122},

publisher = {BMJ},

abstract = {The Good Clinical Practices (GCP) codes of the WHO and the 

 International Conference of Harmonization set international 

 standards for clinical research. But critics argue that they 

 were written without consideration for the challenges faced in 

 low and middle income countries (LMICs). Based on our field 

 experience in LMICs, we developed a non-exhaustive set of 

 recommendations for the improvement of GCP. These cover 3 

 domains: ethical, legal and operational, and 8 specific issues: 

 the double ethical review of 'externally sponsored' trials; the 

 informed consent procedure in minors and in illiterate people; 

 post-trial access to newly-developed products for the trial 

 communities; the role of communities as key research actors; the 

 definition of sponsor; and the guidance for contractual 

 agreements, laboratory quality management systems, and quality 

 assurance of investigational medicinal products. Issues not 

 covered in our analysis include among others biobanking, 

 standard of care, and study designs. The international GCP codes 

 de facto guide national legislators and funding agencies, so the 

 current shortcomings may weaken the regulatory oversight of 

 international research. In addition, activities neglected by GCP 

 are less likely to be implemented or funded. If GCP are meant to 

 serve the interests of global society, a comprehensive revision 

 is needed. The revised guidelines should be strongly rooted in 

 ethics, sensitive to different sociocultural perspectives, and 

 allow consideration for trial-specific and context-specific 

 challenges. This can be only achieved if all stakeholders, 

 including researchers, sponsors, regulators, ethical reviewers 

 and patients' representatives from LMICs, as well as 

 non-commercial researchers and sponsors from affluent countries, 

 are transparently involved in the revision process. We hope that 

 our limited analysis would foster advocacy for a broad and 

 inclusive revision of the international GCP codes, to make them 

 at the same time 'global', 'context centred' and 'patient 

 centred'.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Kabanywanyi2016-lr,

title = {Multi-country evaluation of safety of 

 dihydroartemisinin/piperaquine post-licensure in African public 

 hospitals with electrocardiograms},

author = {Abdunoor M Kabanywanyi and Rita Baiden and Ali M Ali and Muhidin K Mahende and Bernhards R Ogutu and Abraham Oduro and Halidou Tinto and Margaret Gyapong and Ali Sie and Esperanca Sevene and Eusebio Macete and Seth Owusu-Agyei and Alex Adjei and Guillaume Compaor\'{e} and Innocent Valea and Isaac Osei and Abena Yawson and Martin Adjuik and Raymond Akparibo and Mwaka A Kakolwa and Salim Abdulla and Fred Binka},

year  = {2016},

date = {2016-10-01},

journal = {PLoS One},

volume = {11},

number = {10},

pages = {e0164851},

publisher = {Public Library of Science (PLoS)},

abstract = {The antimalarial drug piperaquine is associated with delayed 

 ventricular depolarization, causing prolonged QT interval (time 

 taken for ventricular de-polarisation and re-polarisation). 

 There is a lack of safety data regarding 

 dihydroartemisinin/piperaquine (DHA/PPQ) for the treatment of 

 uncomplicated malaria, which has limited its use. We created a 

 platform where electrocardiograms (ECG) were performed in public 

 hospitals for the safety assessment of DHA/PPQ, at baseline 

 before the use of dihydroartemisinin/piperaquine 

 (Eurartesimtextregistered), and on day 3 (before and after 

 administration of the final dose) and day 7 post-administration. 

 Laboratory analyses included haematology and clinical chemistry. 

 The main objective of the ECG assessment in this study was to 

 evaluate the effect of administration of DHA/PPQ on QTc 

 intervals and the association of QTc intervals with changes in 

 blood biochemistry, full and differential blood count over time 

 after the DHA/PPQ administration. A total of 1315 patients gave 

 consent and were enrolled of which 1147 (87%) had complete 

 information for analyses. Of the enrolled patients 488 (42%), 

 323 (28%), 213 (19%) and 123 (11%) were from Ghana, Burkina 

 Faso, Tanzania and Mozambique, respectively. Median (lower-upper 

 quartile) age was 8 (5-14) years and a quarter of the patients were children under five years of age (n = 287). Changes in 

 blood biochemistry, full and differential blood count were 

 temporal which remained within clinical thresholds and did not 

 require any intervention. The mean QTcF values were 

 significantly higher than on day 1 when measured on day 3 before 

 and after administration of the treatment as well as on day 7, 

 four days after completion of treatment (12, 22 and 4 higher, p 

 \< 0.001). In all age groups the values of QT, QTcF and QTcB were 

 highest on day 3 after drug intake. The mean extreme QTcF 

 prolongation from baseline was lowest on day 3 before drug intake (33 m},

keywords = {},

pubstate = {published},

tppubtype = {article}

}