2021 |
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Journal Articles |
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Mphatso Dennis Phiri, Matthew Cairns, Issaka Zongo, Frederic Nikiema, Modibo Diarra, Rakiswendé Serge Yerbanga, Amadou Barry, Amadou Tapily, Samba Coumare, Ismaila Thera, Irene Kuepfer, Paul Milligan, Halidou Tinto, Alassane Dicko, Jean Bosco Ouédraogo, Brian Greenwood, Daniel Chandramohan, Issaka Sagara In: Clin. Infect. Dis., vol. 73, no. 7, pp. e2379–e2386, 2021, ISSN: 1537-6591 1058-4838, (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. PMID: 33417683 PMCID: PMC8492219). (Abstract | Links | BibTeX | Tags: Antimalarials/therapeutic use, Azithromycin, Azithromycin/therapeutic use, Burkina Faso/epidemiology, Chemoprevention, Child, child mortality, Drug Combinations, duration of protection, Humans, Infant, Malaria/drug therapy/epidemiology/prevention & control, Mali/epidemiology, Preschool, Sahel, seasonal malaria chemoprevention, Seasons) @article{Phiri2021-oy, BACKGROUND: Mass drug administration (MDA) with azithromycin (AZ) is being considered as a strategy to promote child survival in sub-Saharan Africa, but the mechanism by which AZ reduces mortality is unclear. To better understand the nature and extent of protection provided by AZ, we explored the profile of protection by time since administration, using data from a household-randomized, placebo-controlled trial in Burkina Faso and Mali. METHODS: Between 2014 and 2016, 30 977 children aged 3-59 months received seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine plus amodiaquine and either AZ or placebo monthly, on 4 occasions each year. Poisson regression with gamma-distributed random effects, accounting for the household randomization and within-individual clustering of illness episodes, was used to compare incidence of prespecified outcomes between SMC+AZ versus SMC+placebo groups in fixed time strata post-treatment. The likelihood ratio test was used to assess evidence for a time-treatment group interaction. RESULTS: Relative to SMC+placebo, there was no evidence of protection from SMC+AZ against hospital admissions and deaths. Additional protection from SMC+AZ against malaria was confined to the first 2 weeks post-administration (protective efficacy (PE): 24.2% [95% CI: 17.8%, 30.1%]). Gastroenteritis and pneumonia were reduced by 29.9% [21.7; 37.3%], and 34.3% [14.9; 49.3%], respectively, in the first 2 weeks postadministration. Protection against nonmalaria fevers with a skin condition persisted up to 28 days: PE: 46.3% [35.1; 55.6%]. CONCLUSIONS: The benefits of AZ-MDA are broad-ranging but short-lived. To maximize impact, timing of AZ-MDA must address the challenge of targeting asynchronous morbidity and mortality peaks from different causes. | |
Daniel Chandramohan, Issaka Zongo, Issaka Sagara, Matthew Cairns, Rakiswendé-Serge Yerbanga, Modibo Diarra, Frédéric Niki`ema, Amadou Tapily, Frédéric Sompougdou, Djibrilla Issiaka, Charles Zoungrana, Koualy Sanogo, Alassane Haro, Mahamadou Kaya, Abdoul-Aziz Sienou, Seydou Traore, Almahamoudou Mahamar, Ismaila Thera, Kalifa Diarra, Amagana Dolo, Irene Kuepfer, Paul Snell, Paul Milligan, Christian Ockenhouse, Opokua Ofori-Anyinam, Halidou Tinto, Abdoulaye Djimde, Jean-Bosco Ouédraogo, Alassane Dicko, Brian Greenwood Seasonal malaria vaccination with or without seasonal malaria chemoprevention (Journal Article) In: N. Engl. J. Med., vol. 385, no. 11, pp. 1005–1017, 2021, ISSN: 1533-4406 0028-4793, (Copyright © 2021 Massachusetts Medical Society. Place: United States PMID: 34432975). (Abstract | Links | BibTeX | Tags: Amodiaquine/therapeutic use, Antimalarials/adverse effects/therapeutic use, Burkina Faso/epidemiology, Chemoprevention, Combination, Combined Modality Therapy, Double-Blind Method, Drug Combinations, Drug Therapy, Falciparum/epidemiology/mortality/prevention & control, Febrile/etiology, Female, Hospitalization/statistics & numerical data, Humans, Infant, Malaria, Malaria Vaccines/administration & dosage/adverse effects, Male, Mali/epidemiology, Pyrimethamine/therapeutic use, Seasons, Seizures, Sulfadoxine/therapeutic use) @article{Chandramohan2021-qm, BACKGROUND: Malaria control remains a challenge in many parts of the Sahel and sub-Sahel regions of Africa. METHODS: We conducted an individually randomized, controlled trial to assess whether seasonal vaccination with RTS,S/AS01E was noninferior to chemoprevention in preventing uncomplicated malaria and whether the two interventions combined were superior to either one alone in preventing uncomplicated malaria and severe malaria-related outcomes. RESULTS: We randomly assigned 6861 children 5 to 17 months of age to receive sulfadoxine-pyrimethamine and amodiaquine (2287 children [chemoprevention-alone group]), RTS,S/AS01E (2288 children [vaccine-alone group]), or chemoprevention and RTS,S/AS01E (2286 children [combination group]). Of these, 1965, 1988, and 1967 children in the three groups, respectively, received the first dose of the assigned intervention and were followed for 3 years. Febrile seizure developed in 5 children the day after receipt of the vaccine, but the children recovered and had no sequelae. There were 305 events of uncomplicated clinical malaria per 1000 person-years at risk in the chemoprevention-alone group, 278 events per 1000 person-years in the vaccine-alone group, and 113 events per 1000 person-years in the combination group. The hazard ratio for the protective efficacy of RTS,S/AS01E as compared with chemoprevention was 0.92 (95% confidence interval [CI], 0.84 to 1.01), which excluded the prespecified noninferiority margin of 1.20. The protective efficacy of the combination as compared with chemoprevention alone was 62.8% (95% CI, 58.4 to 66.8) against clinical malaria, 70.5% (95% CI, 41.9 to 85.0) against hospital admission with severe malaria according to the World Health Organization definition, and 72.9% (95% CI, 2.9 to 92.4) against death from malaria. The protective efficacy of the combination as compared with the vaccine alone against these outcomes was 59.6% (95% CI, 54.7 to 64.0), 70.6% (95% CI, 42.3 to 85.0), and 75.3% (95% CI, 12.5 to 93.0), respectively. CONCLUSIONS: Administration of RTS,S/AS01E was noninferior to chemoprevention in preventing uncomplicated malaria. The combination of these interventions resulted in a substantially lower incidence of uncomplicated malaria, severe malaria, and death from malaria than either intervention alone. (Funded by the Joint Global Health Trials and PATH; ClinicalTrials.gov number, NCT03143218.). |
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