Malaria Active Epidemiology and Treatment Study

This study has been completed.
Sponsor:
Collaborator:
United States Army Medical Materiel Development Activity
Information provided by (Responsible Party):
Armed Forces Research Institute of Medical Sciences, Thailand
ClinicalTrials.gov Identifier:
NCT01280162
First received: January 19, 2011
Last updated: January 7, 2014
Last verified: January 2014

January 19, 2011
January 7, 2014
September 2010
February 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01280162 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Malaria Active Epidemiology and Treatment Study
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

An observational cohort and malaria treatment study in Cambodia.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malaria
Drug: Dihydroartemisinin piperaquine
40/320 mg tablets, 9 tablets total
Other Name: Artekin, Duo-cotexcin
  • Experimental: 3 day therapy
    Total dose split over 3 days (3 tablets per day)
    Intervention: Drug: Dihydroartemisinin piperaquine
  • Experimental: 2 day therapy
    Total dose split over 2 days (4.5 tablets per day)
    Intervention: Drug: Dihydroartemisinin piperaquine
Lon C, Manning JE, Vanachayangkul P, So M, Sea D, Se Y, Gosi P, Lanteri C, Chaorattanakawee S, Sriwichai S, Chann S, Kuntawunginn W, Buathong N, Nou S, Walsh DS, Tyner SD, Juliano JJ, Lin J, Spring M, Bethell D, Kaewkungwal J, Tang D, Chuor CM, Satharath P, Saunders D. Efficacy of two versus three-day regimens of dihydroartemisinin-piperaquine for uncomplicated malaria in military personnel in northern Cambodia: an open-label randomized trial. PLoS One. 2014 Mar 25;9(3):e93138. doi: 10.1371/journal.pone.0093138. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
December 2012
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Cambodia
 
NCT01280162
WRAIR # 1737, HRPO Log Number A-16251
No
Armed Forces Research Institute of Medical Sciences, Thailand
Armed Forces Research Institute of Medical Sciences, Thailand
United States Army Medical Materiel Development Activity
Principal Investigator: David Saunders, MD, MPH USAMC-AFRIMS
Armed Forces Research Institute of Medical Sciences, Thailand
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP