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Malaria Prevention Cambodia (MPC)

Primary Purpose

Malaria

Status

Terminated

Phase

Not Applicable

Locations

Cambodia

Study Type

Interventional

Intervention

DHA-piperaquine

placebo

About this trial

This is an interventional prevention trial for Malaria focused on measuring Plasmodium falciparum, Plasmodium vivax

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Anlong Veng Referral Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DHA-piperaquine

Placebo

Arm Description

DHA-piperaquine monthly 2 day treatment course

Matching placebo control

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01624337

First Posted

June 17, 2012

Last Updated

July 11, 2016

Sponsor

Armed Forces Research Institute of Medical Sciences, Thailand

Collaborators

National Centre for Parasitology, Entomology and Malaria Control, Cambodia, Royal Cambodian Armed Forces, United States Army Medical Materiel Development Activity

1. Study Identification

Unique Protocol Identification Number

NCT01624337

Brief Title

Malaria Prevention Cambodia

Acronym

MPC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Terminated

Why Stopped

Medication safety concern

Study Start Date

May 2012 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Armed Forces Research Institute of Medical Sciences, Thailand

Collaborators

National Centre for Parasitology, Entomology and Malaria Control, Cambodia, Royal Cambodian Armed Forces, United States Army Medical Materiel Development Activity

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

Plasmodium falciparum, Plasmodium vivax

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

231 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DHA-piperaquine

Arm Type

Experimental

Arm Description

DHA-piperaquine monthly 2 day treatment course

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo control

Intervention Type

Drug

Intervention Name(s)

DHA-piperaquine

Other Intervention Name(s)

Duocotexcin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Protective efficacy

Description

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Cardiac safety of piperaquine as determined by QT interval prolongation

Description

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

Time Frame

4-5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

DAVID SAUNDERS, MD, MPH

Organizational Affiliation

Armed Forces Research Institute of Medical Sciences, Thailand

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chanthap Lon, MD

Organizational Affiliation

Armed Forces Research Institute of Medical Sciences, Thailand

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anlong Veng Referral Hospital

City

Anlong Veng

State/Province

Oddar Meancheay

Country

Cambodia

12. IPD Sharing Statement

Citations:

PubMed Identifier

25092702

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.

Results Reference

background

PubMed Identifier

28193647

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.

Results Reference

derived

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Malaria Prevention Cambodia

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