Evaluation of Recurrent Parasitemia after Artemether-Lumefantrine Treatment for Uncomplicated Malaria in Children in Western Kenya
- Joseph V. Woodring*,
- Bernhards Ogutu,
- David Schnabel,
- John N. Waitumbi,
- Cara H. Olsen,
- Douglas S. Walsh,
- D. Gray Heppner Jr. and
- Mark E. Polhemus
- Walter Reed Army Institute of Research, Silver Spring, Maryland; United States Army Medical Research Unit–Kenya/Kenya Medical Research Institute, Kisumu, Kenya
- ↵*Address correspondence to Joseph V. Woodring, Walter Reed Army Institute of Research, Silver Spring, MD 20910. E-mail: joseph.woodring{at}us.army.mil
Abstract.
From April 2005 to April 2006, a phase 2 malaria vaccine trial in Kenya enrolled 400 children aged 12–47 months. Each received mixed supervised and unsupervised artemether-lumefantrine for uncomplicated malaria, using a standard six-dose regimen, by weight. Children were followed for detection of parasitemia and clinical malaria. A median of two negative malaria blood films occurred during every recurrent parasitemia (RP) episode, suggesting reinfection over late recrudescence. Median time to RP after starting artemether-lumefantrine was 37 days (36–38). Of 2,020 evaluable artemether-lumefantrine treatments, there were no RPs in 99% by day 14, 71% by day 28, and 41% by day 42. By World Health Organization standards, 71% of treatment courses had adequate responses. Although recrudescence in some cannot be ruled out, our cohort had a shorter median time to RP compared with other artemether-lumefantrine treatment studies. This underscores patient counseling on completing all treatment doses for optimal protection from RP.
Disclaimer: The views expressed herein are private and do not reflect official positions of the U.S. Army or U.S. Department of Defense. The opinions expressed are personal and are not to be construed as use guidelines or to contradict or replace current labeling indications and guidelines for the use of artemether-lumefantrine.
Footnotes
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Financial support: This study was funded by the US Department of Defense Global Emerging Infections Surveillance and Response System (GEIS), the Malaria Vaccine Initiative at Program for Appropriate Technology in Health (PATH), the US Agency for International Development, and the Military Infectious Diseases Research Program.
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Ethical review: Study subjects were recruited, screened, and enrolled under a phase II malaria vaccine protocol approved by the Kenyan Medical Research Institute, the Western Institutional Review Board, and the US Army Surgeon General's Institutional Review Board. The trial was registered as NCT 0023990. A subsequent amendment to provide additional data analysis was approved by the Walter Reed Army Institute of Research Human Use Review Committee and the Uniformed Services University of the Health Sciences Institutional Review Board.
- Received July 16, 2009.
- Accepted April 6, 2010.
- ©The American Society of Tropical Medicine and Hygiene
