Malaria Active Epidemiology and Treatment Study

Armed Forces Research Institute of Medical Sciences, Thailand

Status: Completed

Conditions: Malaria

Treatments: Drug: Dihydroartemisinin piperaquine

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01280162

WRAIR # 1737

HRPO Log Number A-16251 (Registry Identifier)

Details and patient eligibility

About

An observational cohort and malaria treatment study in Cambodia.

Full description

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.

Enrollment: 222 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

3 day therapy

Experimental group

Description:

Total dose split over 3 days (3 tablets per day)

Treatment:

Drug: Dihydroartemisinin piperaquine

2 day therapy

Experimental group

Description:

Total dose split over 2 days (4.5 tablets per day)

Treatment:

Drug: Dihydroartemisinin piperaquine