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Completed

NCT Number: NCT01280162

Malaria Active Epidemiology and Treatment Study

An observational cohort and malaria treatment study in Cambodia.

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Key information

Conditions

Malaria Infections Malaria, Falciparum Malaria, Vivax Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oddar Meancheay

Anlong Veaeng, Cambodia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Otherwise healthy volunteer, 18-65 years of age, eligible for care at an RCAF facility, and at risk for contracting malaria
  • Able to provide informed consent
  • Likely to reside in 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
  • Authorized by local commander to participate in the study if on active duty

Exclusion criteria

  • History of allergic reaction or contraindication to DHA or piperaquine
  • Significant acute comorbidity requiring urgent medical intervention
  • 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
  • Clinically significant abnormal EKG, including a QTc interval > 500 ms.
  • Judged by the investigator to be otherwise unsuitable for study participation

Treatment and study plan

Dihydroartemisinin piperaquine

Drug

40/320 mg tablets, 9 tablets total

Other names: Artekin, Duo-cotexcin

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Armed Forces Research Institute of Medical Sciences, Thailand

Other Gov

Collaborators

  • United States Army Medical Materiel Development Activity

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jan 20, 2011
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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