NCT01624337

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

2.3 years

First QC Date

June 17, 2012

Last Update Submit

July 11, 2016

Conditions

Malaria

Keywords

Plasmodium falciparumPlasmodium vivax

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Cardiac safety of piperaquine as determined by QT interval prolongation

    4-5 months

Study Arms (2)

DHA-piperaquine

EXPERIMENTAL

DHA-piperaquine monthly 2 day treatment course

Drug: DHA-piperaquine

Placebo

PLACEBO COMPARATOR

Matching placebo control

Drug: placebo

Interventions

DHA-piperaquineDRUG

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

Also known as: Duocotexcin
DHA-piperaquine
placeboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anlong Veng Referral Hospital

Anlong Veaeng, Oddar Meancheay, Cambodia

Location

Related Publications (2)

  • 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.

    PMID: 25092702BACKGROUND

  • 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.

    PMID: 28193647DERIVED

MeSH Terms

Conditions

MalariaMalaria, FalciparumMalaria, Vivax

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • DAVID SAUNDERS, MD, MPH

    Armed Forces Research Institute of Medical Sciences, Thailand

    PRINCIPAL INVESTIGATOR

  • Chanthap Lon, MD

    Armed Forces Research Institute of Medical Sciences, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Immunology and Medicine

Study Record Dates

First Submitted

June 17, 2012

First Posted

June 20, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2014

Study Completion

June 1, 2015

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

CA(1)