Malaria Prevention Cambodia

Malaria Clinical Trial

— MPC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01624337
• Other study ID #: WRAIR # 1849
• Secondary ID: A-17057
• Status: Terminated
• Phase: N/A
• First received: June 17, 2012
• Last updated: July 11, 2016
• Start date: May 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2016
• Source: Armed Forces Research Institute of Medical Sciences, Thailand
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cambodia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 231
• Est. completion date: June 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• DHA-piperaquine
Drug: Dihydroartemisinin piperaquine 40/320 mg tablets, 9 tablets total Arms: 2 day treatment course (4.5 tablets per day)
• placebo

Locations

Country	Name	City	State
Cambodia	Anlong Veng Referral Hospital	Anlong Veng	Oddar Meancheay

Sponsors (4)

Lead Sponsor	Collaborator
Armed Forces Research Institute of Medical Sciences, Thailand	National Centre for Parasitology, Entomology and Malaria Control, Cambodia, Royal Cambodian Armed Forces, United States Army Medical Materiel Development Activity

Country where clinical trial is conducted

Cambodia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protective efficacy	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.	4 months	No
Secondary	Cardiac safety of piperaquine as determined by QT interval prolongation	To document the effect on the electrocardiogram (EKG), particularly the QTc interval, in patients taking repeated monthly treatment courses of DHA-piperaquine.	4-5 months	Yes

External Links

•   Published Report of Halting