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Antimalarial Drug Resistance With Assessment of Transmission Blocking Activity

NCT01849640 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-07-15

No results posted yet for this study

Summary

This is a two-arm, open label Treatment Study comparing the efficacy, safety, tolerability and pharmacokinetics of a three-day course of Dihydroartemisinin-Piperaquine (DP) with or without single-dose primaquine in patients with uncomplicated Plasmodium falciparum malaria. On the last day of DP therapy, volunteers will be randomized to receive either a single 45 mg dose of primaquine (PQ) or DP treatment only (no primaquine).

Conditions

  • Uncomplicated Plasmodium Falciparum Malaria

Interventions

DRUG

DHA-piperaquine and Primaquine

Subject will be enrolled in open label fashion to a 3-day treatment course of DHA-piperaquine (DP) by directly observed therapy (DOT, all patients will receive a total of 9 tablets containing 40mg DHA and 320mg of piperaquine in divided doses at 0, 24 and 48 hours (3 tablets once per day) for the 3 day course. At completion of DP treatment volunteers will be randomized in an open label fashion to receive a single 45 mg dose of primaquine or no therapy.

Sponsors & Collaborators

  • National Centre for Parasitology, Entomology and Malaria Control, Cambodia

    collaborator OTHER

  • Royal Cambodian Armed Forces

    collaborator UNKNOWN

  • US Department of Defense Armed Forces Health Surveillance Center

    collaborator FED

  • David Saunders

    lead OTHER_GOV

Principal Investigators

  • David Saunders, MD, MPH · Dept. of Immunology and Medicine, Armed Forces Research Institute of Medical Sciences (AFRIMS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-12-31
Completion
2016-06-30

Countries

  • Cambodia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01849640 on ClinicalTrials.gov