Combination therapy for uncomplicated falciparum malaria in Ugandan children: a randomized trial.

Combination therapy for uncomplicated falciparum malaria in Ugandan children: a randomized trial. Research Abstract Details 

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Combination therapy for uncomplicated falciparum malaria in Ugandan children: a randomized trial. Abstract Text:

Grant Dorsey,Sarah Staedke,Tamara D Clark,Denise Njama-Meya,Bridget Nzarubara,Catherine Maiteki-Sebuguzi,Christian Dokomajilar,Moses R Kamya,Philip J Rosenthal,

CONTEXT: Combination therapy is now widely advocated as first-line treatment for uncomplicated malaria in Africa. However, it is not clear which treatment regimens are optimal or how to best assess comparative efficacies in highly endemic areas. OBJECTIVE: To compare the efficacy and safety of 3 leading combination therapies for the treatment of uncomplicated malaria. DESIGN, SETTING, AND PARTICIPANTS: Single-blind randomized clinical trial, conducted between November 2004 and June 2006, of treatment for all episodes of uncomplicated malaria in children in an urban community in Kampala, Uganda. A total of 601 healthy children (aged 1-10 years) were randomly selected and were followed up for 13 to 19 months, receiving all medical care at the study clinic. INTERVENTIONS: Study participants were randomized to receive 1 of 3 combination therapies (amodiaquine plus sulfadoxine-pyrimethamine, amodiaquine plus artesunate, or artemether-lumefantrine) when diagnosed with their first episode of uncomplicated malaria. The same assigned treatment was given for all subsequent episodes. MAIN OUTCOME MEASURE: 28-Day risk of parasitological failure (unadjusted and adjusted by genotyping to distinguish recrudescence from new infection) for each episode of uncomplicated malaria treated with study drugs. RESULTS: Of enrolled children, 329 of 601 were diagnosed with at least 1 episode of uncomplicated malaria, and 687 episodes of Plasmodium falciparum malaria were treated with study drugs. The 28-day risk of treatment failure (unadjusted by genotyping) for individual episodes of malaria were 26.1% (95% CI, 21.1%-32.1%) for amodiaquine plus sulfadoxine-pyrimethamine, 17.4% (95% CI, 13.1%-23.1%) for amodiaquine plus artesunate, and 6.7% (95% CI, 3.9%-11.2%) for artemether-lumefantrine (P<.05 for all pairwise comparisons). When only recrudescent treatment failures were considered, the risks of failure were 14.1% (95% CI, 10.3%-19.2%), 4.6% (95% CI, 2.5%-8.3%), and 1.0% (95% CI, 0.3%-4.0%) for the same order of study drugs, respectively (P< or =.008 for all pairwise comparisons, except amodiaquine plus artesunate vs artemether-lumefantrine, P = .05). There were no deaths or cases of severe malaria. Significant reductions in anemia (9.3% [95% CI, 7.0%-12.0%] at enrollment vs 0.6% [95% CI, 0.1%-2.2%] during the last 2 months of follow-up; P<.001) and asymptomatic parasitemia (18.6% [95% CI, 15.5%-22.1%] at enrollment vs 2.3% [95% CI, 1.5%-3.5%] during the last 2 months of follow-up; P<.001) were observed according to routine testing. CONCLUSIONS: Artemether-lumefantrine was the most efficacious treatment for uncomplicated malaria in the study population. With all study regimens, the provision of prompt and reasonably effective facility-based treatment was associated with good outcomes in long-term health measures. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN37517549.

Combination therapy for uncomplicated falciparum malaria in Ugandan children: a randomized trial. Publishing Authors By Initials

G Dorsey,S Staedke,TD Clark,D Njama-Meya,B Nzarubara,C Maiteki-Sebuguzi,C Dokomajilar,MR Kamya,PJ Rosenthal,

For similar population characteristics: population: urban population research abstracts see: population characteristics: population: urban population research

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Combination therapy for uncomplicated falciparum malaria in Ugandan children: a randomized trial. Journal Published:

PUBLICATION TYPE: Research Support, Non-U.S. Gov

Journal: JAMA : the journal of the American Medical Associa

VOLUME: 297

Page Numbers: 2210-9

Journal Abbreviation: JAMA

ISSN: 1538-3598

DAY: 23

MONTH: May

YEAR: 2007

Combination therapy for uncomplicated falciparum malaria in Ugandan children: a randomized trial. Information

Number of References:

LANGUAGE: eng

NlmUniqueID: 7501160

Combination therapy for uncomplicated falciparum malaria in Ugandan children: a randomized trial. Keywords Mesh Terms:

KEYWORDS: Urban Population

MESH TERMS: therapeutic use

Chemical & Substance for Abstract: Combination therapy for uncomplicated falciparum malaria in Ugandan children: a randomized trial. Information

Substance Name: Amodiaquine

Registry Number: 86-42-0

Grant and Affiliation Information for Combination therapy for uncomplicated falciparum malaria in Ugandan children: a randomized trial.

AFFILIATION: Department of Medicine, San Francisco General Hospital, University of California, San Francisco, CA 94143, USA. gdorsey@medsfgh.ucsf.edu

Country: United States

AGENCY: United States NIAID

GRANT: U01 AI052142

ACRONYM: AI

MEDLINETA: JAMA

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