Malaria Active Epidemiology and Treatment Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-12-31

Brief Summary

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An observational cohort and malaria treatment study in Cambodia.

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Detailed Description

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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.

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3 day therapy

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

Group Type EXPERIMENTAL

Dihydroartemisinin piperaquine

Intervention Type DRUG

40/320 mg tablets, 9 tablets total

2 day therapy

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

Group Type EXPERIMENTAL

Dihydroartemisinin piperaquine

Intervention Type DRUG

40/320 mg tablets, 9 tablets total

Interventions

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Dihydroartemisinin piperaquine

40/320 mg tablets, 9 tablets total

Intervention Type DRUG

Other Intervention Names

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Artekin, Duo-cotexcin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes