Protective efficacy and safety of three antimalarial regimens for the prevention of malaria in young Ugandan children: a randomized controlled trial

Chemoprevention offers a promising strategy for prevention of malaria in African children. However, the optimal chemoprevention drug and dosing strategy is unclear in areas of year-round transmission and resistance to many antimalarial drugs. To compare three available regimens, we conducted an open...

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Bibliographic Details
Published in:PLoS medicine 2014-08, Vol.11 (8), p.e1001689-e1001689
Main Authors: Bigira, Victor, Kapisi, James, Clark, Tamara D, Kinara, Stephen, Mwangwa, Florence, Muhindo, Mary K, Osterbauer, Beth, Aweeka, Francesca T, Huang, Liusheng, Achan, Jane, Havlir, Diane V, Rosenthal, Philip J, Kamya, Moses R, Dorsey, Grant
Format: Article
Language:English
Subjects:
Antimalarials
Antimalarials - therapeutic use
Artemisinins - therapeutic use
Caregivers
Clinical trials
Cohort Studies
Disease transmission
Dosage and administration
Drug Combinations
Drug dosages
Female
Humans
Incidence
Infant
Insecticides
Intervention
Malaria
Malaria - drug therapy
Malaria - epidemiology
Malaria - parasitology
Male
Medicine and Health Sciences
Parasites
Prevention
Pyrimethamine - therapeutic use
Quinolines - therapeutic use
Safety and security measures
Studies
Sulfadoxine - therapeutic use
Trimethoprim, Sulfamethoxazole Drug Combination - therapeutic use
Uganda - epidemiology
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Summary:Chemoprevention offers a promising strategy for prevention of malaria in African children. However, the optimal chemoprevention drug and dosing strategy is unclear in areas of year-round transmission and resistance to many antimalarial drugs. To compare three available regimens, we conducted an open-label randomized controlled trial of chemoprevention in Ugandan children. This study was conducted between June 28, 2010, and September 25, 2013. 400 infants were enrolled and 393 randomized at 6 mo of age to no chemoprevention, monthly sulfadoxine-pyrimethamine (SP), daily trimethoprim-sulfamethoxazole (TS), or monthly dihydroartemisinin-piperaquine (DP). Study drugs were administered at home without supervision. Piperaquine (PQ) levels were used as a measure of compliance in the DP arm. Participants were given insecticide-treated bednets, and caregivers were encouraged to bring their child to a study clinic whenever they were ill. Chemoprevention was stopped at 24 mo of age, and participants followed-up an additional year. Primary outcome was the incidence of malaria during the intervention period. During the intervention, the incidence of malaria in the no chemoprevention arm was 6.95 episodes per person-year at risk. Protective efficacy was 58% (95% CI, 45%-67%, p
ISSN:1549-1676
1549-1277
1549-1676
DOI:10.1371/journal.pmed.1001689