Malaria Prevention Cambodia

Study Overview
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Brief Summary
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Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.

Detailed Description
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This is a two arm, randomized, double-blind, placebo controlled cohort study to determine the protective efficacy of a monthly 2 day treatment course of Dihydroartemisinin-Piperaquine (DP) in adult volunteers in malaria endemic areas of Cambodia.

Official Title
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A Randomized, Double Blind, Placebo-controlled Clinical Trial of Monthly DHA-piperaquine for Malaria Prevention in Cambodia.

Conditions
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Malaria

Intervention / Treatment
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* Drug: DHA-piperaquine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteer 18-65 years of age Able to give informed consent Likely to reside in malaria endemic area for the duration of the study Available for follow-up for anticipated study duration, and agrees to participate for the duration of the study Agrees not to seek outside medical care for febrile illness, except in emergency situations, unless referred by study team Authorized by local commander to participate in the study if on active duty Exclusion Criteria: Known allergy or other contraindication to DHA, piperaquine treatment, and/or primaquine treatment Significant acute comorbidity requiring urgent medical intervention Positive malaria blood smear. Treatment with an antimalarial drug in the past 30 days. 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 Significantly abnormal EKG including a QTcF interval greater than 450ms at baseline (or 470ms for females) using Fridericia's correction Regular current use of known QTc prolonging medications History of sudden cardiac death in an immediate family member, or personal history of known symptomatic coronary artery disease or arrhythmias Judged by the investigator to be otherwise unsuitable for study participation or non-compliant with study requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHA-piperaquine<br>DHA-piperaquine monthly 2 day treatment course | Drug: DHA-piperaquine<br>* Drug: Dihydroartemisinin piperaquine 40/320 mg tablets, 9 tablets total Arms: 2 day treatment course (4.5 tablets per day)<br>* Other names: Duocotexcin;|
| Placebo Comparator: Placebo<br>Matching placebo control | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protective efficacy | To quantify protective efficacy for the prevention of malaria infection in a setting of mixed multidrug resistant P. falciparum and P. vivax malaria, particularly in non-immune volunteers, in two treatment groups - monthly DHA-piperaquine vs. placebo. Protective efficacy will be defined by reduction in the incidence of malaria between treatment and placebo groups. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac safety of piperaquine as determined by QT interval prolongation | To document the effect on the electrocardiogram (EKG), particularly the QTc interval, in patients taking repeated monthly treatment courses of DHA-piperaquine. | 4-5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plasmodium falciparum, Plasmodium vivax