Malaria Active Epidemiology and Treatment Study

An Active Malaria Epidemiology Cohort Study With Evaluation of a 2 Day Versus 3 Day Treatment Regimen of Dihydroartemisinin (DHA)-Piperaquine for Patients With Uncomplicated Malaria

An observational cohort and malaria treatment study in Cambodia.

This is an active observational Cohort Study of malaria epidemiology with a nested two arm, randomized, open label Treatment Study comparing the efficacy, safety, tolerability and pharmacokinetics of a two versus three day course of Dihydroartemisinin-Piperaquine (DP) for those developing uncomplicated malaria. At the conclusion of the Cohort Study, a subset of volunteers with documented exposure to Plasmodium vivax during the study will be treated with primaquine as presumptive anti-relapse therapy directed against the exoerythrocytic malaria stages of P. vivax, and followed passively for an additional 6 months.

Inclusion Criteria:

1. Otherwise healthy volunteer, 18-65 years of age, eligible for care at an RCAF facility, and at risk for contracting malaria
2. Able to provide informed consent
3. Likely to reside in endemic area for the duration of the study
4. Available for follow-up for anticipated study duration, and agrees to participate for the duration of the study
5. Authorized by local commander to participate in the study if on active duty

Exclusion Criteria:

1. History of allergic reaction or contraindication to DHA or piperaquine
2. Significant acute comorbidity requiring urgent medical intervention
3. Pregnant or lactating female, or a female of childbearing age who does not agree to use a highly effective method of birth control during the study
4. Clinically significant abnormal EKG, including a QTc interval > 500 ms.
5. Judged by the investigator to be otherwise unsuitable for study participation