Malaria Active Epidemiology and Treatment Study

Not Applicable

Completed

• Conditions: Malaria
• Interventions: Drug: Dihydroartemisinin piperaquine

• Registration Number: NCT01280162
• Lead Sponsor: Armed Forces Research Institute of Medical Sciences, Thailand

Brief Summary

An observational cohort and malaria treatment study in Cambodia.

Detailed 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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-19
• Study First Posted: 2011-01-20
• Primary Completion: 2011-02
• Study Completion: 2012-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 day therapy	Dihydroartemisinin piperaquine	Total dose split over 2 days (4.5 tablets per day)
3 day therapy	Dihydroartemisinin piperaquine	Total dose split over 3 days (3 tablets per day)

Primary Outcome Measures

Name	Time	Method
Adequate clinical and parasitological response to a treatment regimen of DHA-PIP for Plasmodium falciparum	6 months	Number of malaria recurrences for 2 and 3 day DHA-PIP drug regimens within 42 days after treatment of malaria infection, diagnosed by positive PCR-corrected malaria microscopy.

Secondary Outcome Measures

Name	Time	Method
Number of Cambodian study subjects with reduced or null activity hepatic cytochrome P450 2D6 alleles	1 year	Using Polymerase Chain Reaction-based bead array assays, genotype the human hepatic CYP2D6 allele in study participants giving informed consent for genetic testing
Number of subjects with reduced or null hepatic CYP2D6 enzyme phenotype using activity-score A system	1 year	For each CYP2D6 genotype determined, use the AS-A system to assign predicted metabolism phenotype

Trial Locations

Locations (1)

Oddar Meancheay; 🇰🇭 Anlong Veng, Cambodia