Malaria Active Epidemiology and Treatment Study

March 1, 2021 updated by: Armed Forces Research Institute of Medical Sciences, Thailand

An Active Malaria Epidemiology Cohort Study With Evaluation of a 2 Day Versus 3 Day Treatment Regimen of Dihydroartemisinin (DHA)-Piperaquine for Patients With Uncomplicated Malaria

An observational cohort and malaria treatment study in Cambodia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

222

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
      • Anlong Veng, Cambodia
        • Oddar Meancheay

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

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3 day therapy
Total dose split over 3 days (3 tablets per day)
Drug: Dihydroartemisinin piperaquine
40/320 mg tablets, 9 tablets total
Other Names:
  • Artekin, Duo-cotexcin
Experimental: 2 day therapy
Total dose split over 2 days (4.5 tablets per day)
Drug: Dihydroartemisinin piperaquine
40/320 mg tablets, 9 tablets total
Other Names:
  • Artekin, Duo-cotexcin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequate clinical and parasitological response to a treatment regimen of DHA-PIP for Plasmodium falciparum
Time Frame: 6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Cambodian study subjects with reduced or null activity hepatic cytochrome P450 2D6 alleles
Time Frame: 1 year
Using Polymerase Chain Reaction-based bead array assays, genotype the human hepatic CYP2D6 allele in study participants giving informed consent for genetic testing
1 year
Number of subjects with reduced or null hepatic CYP2D6 enzyme phenotype using activity-score A system
Time Frame: 1 year
For each CYP2D6 genotype determined, use the AS-A system to assign predicted metabolism phenotype
1 year

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

United States Army Medical Materiel Development Activity

Investigators

  • Principal Investigator: Michele D. Spring, MD, MSPH, USAMC-AFRIMS

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

September 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 19, 2011

First Submitted That Met QC Criteria

January 19, 2011

First Posted (Estimate)

January 20, 2011

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WRAIR # 1737
  • HRPO Log Number A-16251 (Registry 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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