Clinical trial NCT01624337: Malaria Prevention Cambodia
Official title: A Randomized, Double Blind, Placebo-controlled Clinical Trial of Monthly DHA-piperaquine for Malaria Prevention in Cambodia.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malaria
Keywords: Plasmodium falciparum
Plasmodium vivax
Lead sponsor: Armed Forces Research Institute of Medical Sciences, Thailand
Sponsor class: OTHER_GOV
Collaborators: name: National Centre for Parasitology, Entomology and Malaria Control, Cambodia
name: Royal Cambodian Armed Forces
name: United States Army Medical Materiel Development Activity
First posted: 2012-06-20
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Known allergy or other contraindication to DHA, piperaquine treatment, and/or primaquine treatment
2. Significant acute comorbidity requiring urgent medical intervention
3. Positive malaria blood smear.
4. Treatment with an antimalarial drug in the past 30 days.
5. 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
6. Significantly abnormal EKG including a QTcF interval greater than 450ms at baseline (or 470ms for females) using Fridericia's correction
7. Regular current use of known QTc prolonging medications
8. History of sudden cardiac death in an immediate family member, or personal history of known symptomatic coronary artery disease or arrhythmias
9. Judged by the investigator to be otherwise unsuitable for study participation or non-compliant with study requirements

Primary outcomes:
measure: Protective efficacy
timeFrame: 4 months
Secondary outcomes:
measure: Cardiac safety of piperaquine as determined by QT interval prolongation
timeFrame: 4-5 months
Other outcomes:
Locations:
city: Anlong Veng
country: Cambodia
facility: Anlong Veng Referral Hospital
state: Oddar Meancheay
Study officials:
affiliation: Armed Forces Research Institute of Medical Sciences, Thailand
name: DAVID SAUNDERS, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Armed Forces Research Institute of Medical Sciences, Thailand
name: Chanthap Lon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manning J, Vanachayangkul P, Lon C, Spring M, So M, Sea D, Se Y, Somethy S, Phann ST, Chann S, Sriwichai S, Buathong N, Kuntawunginn W, Mitprasat M, Siripokasupkul R, Teja-Isavadharm P, Soh E, Timmermans A, Lanteri C, Kaewkungwal J, Auayporn M, Tang D, Chour CM, Prom S, Haigney M, Cantilena L, Saunders D. Randomized, double-blind, placebo-controlled clinical trial of a two-day regimen of dihydroartemisinin-piperaquine for malaria prevention halted for concern over prolonged corrected QT interval. Antimicrob Agents Chemother. 2014 Oct;58(10):6056-67. doi: 10.1128/AAC.02667-14. Epub 2014 Aug 4.
citation: Vanachayangkul P, Lon C, Spring M, Sok S, Ta-Aksorn W, Kodchakorn C, Pann ST, Chann S, Ittiverakul M, Sriwichai S, Buathong N, Kuntawunginn W, So M, Youdaline T, Milner E, Wojnarski M, Lanteri C, Manning J, Prom S, Haigney M, Cantilena L, Saunders D. Piperaquine Population Pharmacokinetics and Cardiac Safety in Cambodia. Antimicrob Agents Chemother. 2017 Apr 24;61(5):e02000-16. doi: 10.1128/AAC.02000-16. Print 2017 May.