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Study on the Treatment of Vivax Malaria

NCT01074905 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 655

Last updated 2013-08-28

No results posted yet for this study

Summary

This is a randomised open label trial with follow up for 1 year. 660 adults and children above 6 months diagnosed with acute Plasmodium vivax will be randomised into 3 groups, either chloroquine, artesunate, or chloroquine/primaquine therapy. Participants will be screened on the day of inclusion then followed weekly for 8 visits and every 4 weeks until week 52. The primary objective of the study is to compare the efficacy of the WHO and Thai Ministry of Public Health recommended radical curative regimen of chloroquine and primaquine with the currently used monotherapy regimens of chloroquine and artesunate along the Thai-Burmese border.

Conditions

  • Vivax Malaria

Interventions

DRUG

Artesunate

2 mg/kg/day as single daily dose given for 5 days; maximum dose range is 1.6 to 2.4 mg/kg/day or a total of 8 to 12 mg/kg.

DRUG

Chloroquine

25 mg base/kg given in divided doses (10,10,5) over 3 days; Absolute range 20-30 mg/kg.

DRUG

Chloroquine/Primaquine

Chloroquine 3 days and Primaquine 14 days

Sponsors & Collaborators

  • Mahidol University

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Francois Nosten, MD · Shoklo Malaria Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Thailand

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 NCT01074905 on ClinicalTrials.gov