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Study of ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria

NCT01288820 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2013-08-29

No results posted yet for this study

Summary

This randomized clinical trial will be conducted in subjects with uncomplicated Plasmodium vivax malaria during November 2010 to March 2012. The aim of the study is to compare the efficacy and safety of artesunate-amodiaquine plus primaquine (AS-AQ + PQ) and dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) in uncomplicated vivax malaria. The significance of the study is to find alternative drug for treating patients with vivax malaria in case the standard treatment is not available or become resistance. This study will give thorough information about the efficacy and safety of 2 artemisinin-based combination therapies (ACTs) in combination with primaquine. It will also inform the Indonesian Ministry of Health on their suggested policies for radical cure of vivax malaria, and provides evidence based treatment options for chloroquine resistant vivax malaria. This study will also provide information about prevalence of glucose-6-phosphate dehydrogenase (G6PD) deficiency and G6PD variants in North Sumatera population.

Conditions

  • Vivax Malaria

Interventions

DRUG

Dihydroartemisinin/piperaquine + primaquine

Dihydroartemisinin 2.25mg/kg and piperaquine 16-18mg/kg on day 0, 1, and 2 and primaquine 15 mg/kg form day 0-13.

DRUG

Artesunate-amodiaquine + primaquine

Standard treatment with artesunate-amodiaquine plus primaquine, with artesunate 4mg/kg and amodiaquine 10mg/kg on day 0, 1, and 2 and primaquine 15 mg/kg form day 0-13.

Sponsors & Collaborators

  • Mahidol University

    collaborator OTHER

  • Indonesia-MoH

    collaborator OTHER_GOV

  • University of Oxford

    lead OTHER

Principal Investigators

  • Ayodhia Pitaloka Pasaribu, MD · Department of Pediatric, Sumatera Utara University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Indonesia

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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 NCT01288820 on ClinicalTrials.gov