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J Infect Dis. 2007 Dec 1;196(11):1595-602. Epub 2007 Oct 25.

Intermittent preventive treatment against malaria in infants in Gabon--a randomized, double-blind, placebo-controlled trial.

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  • 1Medical Research Unit, Albert Schweitzer Hospital, Lambarene, Gabon. martin.grobusch@wits.ac.za

Abstract

BACKGROUND:

Intermittent preventive treatment aims to maximize the protective effects of malaria chemoprophylaxis while minimizing the deleterious effects.

METHODS:

In Gabon, 1189 infants received either sulfadoxine-pyrimethamine (SP; 250 and 12.5 mg, respectively) or placebo at 3, 9, and 15 months of age. Children were actively followed-up until 18 months of age.

RESULTS:

In the intention-to-treat population at 18 months of follow-up, 84 children (17%) in the SP group had > or =1 episode of anemia, versus 108 (21%) in the placebo group (protective efficacy, 22% [95% confidence interval {CI}, -1% to 40%]; P=.06). In the intervention group, there were 66 episodes during 485 person-years at risk, compared with 79 episodes during 497 years in the placebo group (protective efficacy, 17% [95% CI, -24% to 45%; P=.36). The effects were similar at 12 months of follow-up. The study drug was safe and well tolerated.

CONCLUSIONS:

The intervention was efficacious, producing a reduction in risk for anemia but a smaller effect against malaria. It is a valuable additional tool to control malaria in a highly vulnerable age group. Remaining important questions are currently being addressed in further studies.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier: NCT00167843.

PMID:
18008242
[PubMed - indexed for MEDLINE]
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