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Combination Therapy for Uncomplicated Falciparum Malaria in Ugandan
A Randomized Trial
Grant Dorsey, MD, PhD; Sarah Staedke, MD; Tamara D. Clark, MPH;
Denise Njama-Meya, MB ChB, MSc; Bridget Nzarubara, MB ChB;
Catherine Maiteki-Sebuguzi, MB ChB; Christian Dokomajilar, BA; Moses
R. Kamya, MB ChB, MMed; Philip J. Rosenthal, MD
JAMA. 2007;297(20):2210-2219.
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 .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 Identifier: ISRCTN37517549
Author Affiliations: Department of Medicine, San Francisco General Hospital,
University of California, San Francisco (Drs Dorsey and Rosenthal, Ms Clark,
and Mr Dokomajilar); London School of Hygiene and Tropical Medicine,
London, England (Dr Staedke); and Makerere University Medical School,
Kampala, Uganda (Drs Njama-Meya, Nzarubara, Maiteki-Sebuguzi, and


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