Clinical Trial: Malaria Prevention Cambodia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.

Detailed Summary: 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.
Sponsor: Armed Forces Research Institute of Medical Sciences, Thailand

Current Primary Outcome: Protective efficacy [ Time Frame: 4 months ]

To quantify protective efficacy for the prevention of malaria infection in a setting of mixed multidrug resistant P. falciparum and P. vivax malaria, particularly in non-immune volunteers, in two treatment groups - monthly DHA-piperaquine vs. placebo.

Protective efficacy will be defined by reduction in the incidence of malaria between treatment and placebo groups.



Original Primary Outcome: Same as current

Current Secondary Outcome: Cardiac safety of piperaquine as determined by QT interval prolongation [ Time Frame: 4-5 months ]

To document the effect on the electrocardiogram (EKG), particularly the QTc interval, in patients taking repeated monthly treatment courses of DHA-piperaquine.


Original Secondary Outcome: Same as current

Information By: Armed Forces Research Institute of Medical Sciences, Thailand

Dates:
Date Received: June 17, 2012
Date Started: May 2012
Date Completion:
Last Updated: July 11, 2016
Last Verified: July 2016