Malaria Active Epidemiology and Treatment Study

Armed Forces Research Institute of Medical Sciences, Thailand222 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

222

Conditions

Malaria

Interventions

Dihydroartemisinin piperaquineDRUG

40/320 mg tablets, 9 tablets total

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oddar Meancheay

Anlong Veaeng, Cambodia

Outcomes

Primary Outcomes

Adequate clinical and parasitological response to a treatment regimen of DHA-PIP for Plasmodium falciparum

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.

Time frame: 6 months

Secondary Outcomes

Number of Cambodian study subjects with reduced or null activity hepatic cytochrome P450 2D6 alleles

Using Polymerase Chain Reaction-based bead array assays, genotype the human hepatic CYP2D6 allele in study participants giving informed consent for genetic testing

Time frame: 1 year

Number of subjects with reduced or null hepatic CYP2D6 enzyme phenotype using activity-score A system

For each CYP2D6 genotype determined, use the AS-A system to assign predicted metabolism phenotype

Time frame: 1 year

Data from ClinicalTrials.gov

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