Malaria Prevention Cambodia (MPC)

Armed Forces Research Institute of Medical Sciences, Thailand

Status: Terminated

Conditions: Malaria

Treatments: Drug: placebo; Drug: DHA-piperaquine

Study type: Interventional

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

Identifiers

NCT01624337

A-17057 (Other Identifier)

WRAIR # 1849

Details and patient eligibility

About

Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.

Full description

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.

Enrollment: 231 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Volunteer 18-65 years of age
2. Able to give informed consent
3. Likely to reside in malaria 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. Agrees not to seek outside medical care for febrile illness, except in emergency situations, unless referred by study team
6. Authorized by local commander to participate in the study if on active duty

Exclusion criteria

1. Known allergy or other contraindication to DHA, piperaquine treatment, and/or primaquine treatment
2. Significant acute comorbidity requiring urgent medical intervention
3. Positive malaria blood smear.
4. Treatment with an antimalarial drug in the past 30 days.
5. 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
6. Significantly abnormal EKG including a QTcF interval greater than 450ms at baseline (or 470ms for females) using Fridericia's correction
7. Regular current use of known QTc prolonging medications
8. History of sudden cardiac death in an immediate family member, or personal history of known symptomatic coronary artery disease or arrhythmias
9. Judged by the investigator to be otherwise unsuitable for study participation or non-compliant with study requirements

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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231 participants in 2 patient groups, including a placebo group

DHA-piperaquine

Experimental group

Description:

DHA-piperaquine monthly 2 day treatment course

Treatment:

Drug: DHA-piperaquine

Placebo

Placebo Comparator group

Description:

Matching placebo control

Treatment:

Drug: placebo