Malaria Prevention Cambodia (MPC)

July 11, 2016 updated by: Philip Smith, Armed Forces Research Institute of Medical Sciences, Thailand

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

231

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cambodia
    • Oddar Meancheay
      • Anlong Veng, Oddar Meancheay, Cambodia
        • Anlong Veng Referral Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DHA-piperaquine
DHA-piperaquine monthly 2 day treatment course
Drug: DHA-piperaquine

Drug: Dihydroartemisinin piperaquine

40/320 mg tablets, 9 tablets total Arms: 2 day treatment course (4.5 tablets per day)

Other Names:
  • Duocotexcin
Placebo Comparator: Placebo
Matching placebo control
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protective efficacy
Time Frame: 4 months

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
Time Frame: 4-5 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Forces Research Institute of Medical Sciences, Thailand

Collaborators

National Centre for Parasitology, Entomology and Malaria Control, Cambodia
United States Army Medical Materiel Development Activity
Royal Cambodian Armed Forces

Investigators

  • Principal Investigator: DAVID SAUNDERS, MD, MPH, Armed Forces Research Institute of Medical Sciences, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 17, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WRAIR # 1849
  • A-17057 (Other Identifier: US Army Medical Research and Materiel Command)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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