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Malaria Prevention Cambodia (MPC)

This study has been terminated.
(Medication safety concern)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01624337
First Posted: June 20, 2012
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Centre for Parasitology, Entomology and Malaria Control, Cambodia
Royal Cambodian Armed Forces
United States Army Medical Materiel Development Activity
Information provided by (Responsible Party):
Philip Smith, Armed Forces Research Institute of Medical Sciences, Thailand
  Purpose
Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.

Condition Intervention
Malaria Drug: DHA-piperaquine Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double Blind, Placebo-controlled Clinical Trial of Monthly DHA-piperaquine for Malaria Prevention in Cambodia.

Resource links provided by NLM:


Further study details as provided by Philip Smith, Armed Forces Research Institute of Medical Sciences, Thailand:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Cardiac safety of piperaquine as determined by QT interval prolongation [ Time Frame: 4-5 months ]
    To document the effect on the electrocardiogram (EKG), particularly the QTc interval, in patients taking repeated monthly treatment courses of DHA-piperaquine.


Estimated Enrollment: 231
Study Start Date: May 2012
Study Completion Date: June 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHA-piperaquine
DHA-piperaquine monthly 2 day treatment course
Drug: DHA-piperaquine

Drug: Dihydroartemisinin piperaquine

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

Other Name: Duocotexcin
Placebo Comparator: Placebo
Matching placebo control
Drug: placebo

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624337


Locations
Cambodia
Anlong Veng Referral Hospital
Anlong Veng, Oddar Meancheay, Cambodia
Sponsors and Collaborators
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
Investigators
Principal Investigator: 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
  More Information

Additional Information:
Publications:
Responsible Party: Philip Smith, Chief, Department of Immunology and Medicine, Armed Forces Research Institute of Medical Sciences, Thailand
ClinicalTrials.gov Identifier: NCT01624337     History of Changes
Other Study ID Numbers: WRAIR # 1849
A-17057 ( Other Identifier: US Army Medical Research and Materiel Command )
First Submitted: June 17, 2012
First Posted: June 20, 2012
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by Philip Smith, Armed Forces Research Institute of Medical Sciences, Thailand:
Plasmodium falciparum
Plasmodium vivax

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Piperaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents