Trial | NCT01624337  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    231
Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.
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 Started
May 31
2012
Primary Completion
Aug 31
2014
Study Completion
Jun 30
2015
Last Update
Jul 12
2016
Estimate

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

Drug placebo

DHA-piperaquine Experimental

DHA-piperaquine monthly 2 day treatment course

Placebo Placebo Comparator

Matching placebo control

Criteria 

Inclusion Criteria:

Volunteer 18-65 years of age
Able to give informed consent
Likely to reside in malaria 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
Agrees not to seek outside medical care for febrile illness, except in emergency situations, unless referred by study team
Authorized by local commander to participate in the study if on active duty

Exclusion Criteria:

Known allergy or other contraindication to DHA, piperaquine treatment, and/or primaquine treatment
Significant acute comorbidity requiring urgent medical intervention
Positive malaria blood smear.
Treatment with an antimalarial drug in the past 30 days.
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
Significantly abnormal EKG including a QTcF interval greater than 450ms at baseline (or 470ms for females) using Fridericia's correction
Regular current use of known QTc prolonging medications
History of sudden cardiac death in an immediate family member, or personal history of known symptomatic coronary artery disease or arrhythmias
Judged by the investigator to be otherwise unsuitable for study participation or non-compliant with study requirements
No Results Posted