A Randomized, Double Blind, Placebo-controlled Clinical Trial of Monthly DHA-piperaquine for Malaria Prevention in Cambodia.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 231
- Locations
- 1
- Primary Endpoint
- Protective efficacy
Study Overview
Brief Summary
Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
DHA-piperaquine
DHA-piperaquine monthly 2 day treatment course
Intervention: DHA-piperaquine (Drug)
Placebo
Matching placebo control
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Cardiac safety of piperaquine as determined by QT interval prolongation(4-5 months)
Investigators
Philip Smith
Chief, Department of Immunology and Medicine
Armed Forces Research Institute of Medical Sciences, Thailand