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Malaria Active Epidemiology and Treatment Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Armed Forces Research Institute of Medical Sciences, Thailand.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
United States Army Medical Materiel Development Activity
Information provided by:
Armed Forces Research Institute of Medical Sciences, Thailand
ClinicalTrials.gov Identifier:
NCT01280162
First received: January 19, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Malaria
 Drug: Dihydroartemisinin piperaquine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Active Malaria Epidemiology Cohort Study With Evaluation of a 2 Day Versus 3 Day Treatment Regimen of DHA-Piperaquine for Patients With Uncomplicated Malaria

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Armed Forces Research Institute of Medical Sciences, Thailand:

Primary Outcome Measures:
  • Comparative efficacy. [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
    Comparative rates of malaria recurrence between the 2 and 3 day DP regimens at 42 days after treatment of malaria infection, diagnosed by positive PCR-corrected malaria microscopy.


Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Artekin, Duo-cotexcin

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280162

Locations
Cambodia
Oddar Meancheay
Oddar Meancheay, Cambodia
Sponsors and Collaborators
Armed Forces Research Institute of Medical Sciences, Thailand
United States Army Medical Materiel Development Activity
Investigators
Principal Investigator: David Saunders, MD, MPH USAMC-AFRIMS
  More Information

No publications provided

Responsible Party: PI - David Saunders, Chief, Clinical Trials, USAMC-AFRIMS, Department of Immunology and Medicine
ClinicalTrials.gov Identifier: NCT01280162     History of Changes
Other Study ID Numbers: WRAIR # 1737, HRPO Log Number A-16251
Study First Received: January 19, 2011
Last Updated: January 19, 2011
Health Authority: Cambodia: Ministry of Health
Cambodia: National Ethical Committee for Health Research

Keywords provided by Armed Forces Research Institute of Medical Sciences, Thailand:
Plasmodium falciparum, Plasmodium vivax

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Dihydroquinghaosu
Artemisinins
Piperaquine
 Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013