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Arterolane-PQP Versus DHA-PQP in Uncomplicated Falciparum Malaria in Eastern Myanmar

NCT02461186 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2015-11-03

No results posted yet for this study

Summary

Emerging resistance to artemisinins and their partner drugs severely threatens the treatment of falciparum malaria in Myanmar with artemisinin combination therapies. To inform drug policy, it is crucial to evaluate alternative antimalarial treatments.

The investigators here propose a randomized clinical trial comparing parasite clearance parameters and efficacy of 3 days arterolane-piperaquine with standard treatment with 3 days dihydroartemisinin (DHA)-piperaquine in adult patients with uncomplicated falciparum malaria in Myanmar stratified for the presence of "K13" mutation in the infecting parasite strains.

Conditions

  • Uncomplicated Falciparum Malaria
  • Artemisinin-resistant

Interventions

DRUG

Arterolane maleate-piperaquine phosphate (Synriam)

DRUG

Dihydroartemisinin-piperaquine phosphate (Duocotexin)

Sponsors & Collaborators

  • Mahidol Oxford Tropical Medicine Research Unit

    collaborator OTHER

  • Department of Medical Research, Lower Myanmar

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Arjen M Dondorp, MD · Mahidol Oxfrod Tropical Medicine Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-06-30
Completion
2017-06-30

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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 NCT02461186 on ClinicalTrials.gov