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P. Knowlesi Trial of Artesunate-mefloquine Versus Chloroquine

NCT01708876 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2015-04-09

No results posted yet for this study

Summary

Preliminary studies have supported the background efficacy of local standard anti-malarial medications in the treatment of uncomplicated knowlesi malaria, however this has not been tested systematically and there are no current WHO treatment guidelines for this infection. There are both health cost benefits to a more rapidly acting agent, and due to difficulties with microscopic identification there may be more effective treatment for all malaria species if an aligned treatment guideline could be supported. In addition, no therapeutic efficacy monitoring of current first line anti-malarials used for the treatment of P. vivax malaria have been conducted in Malaysia.

The investigators aim to test whether the fixed combination of artesunate-mefloquine is superior to chloroquine in order to define the optimal treatment for both uncomplicated P. knowlesi and P. vivax infection in both adults and children in this region.

Conditions

  • Uncomplicated Plasmodium Knowlesi Malaria

Interventions

DRUG

Artesunate-mefloquine

DRUG

Chloroquine

DRUG

Primaquine

Given to P. vivax patients only. Delayed administration at day 28; 0.5mg/kg for children or 45mg for adults; normal G6PD activity (once daily administration for 14 days); moderate G6PD deficiency (once weekly for 8 weeks); severe G6PD deficiency (contraindicated / not given).

Sponsors & Collaborators

  • Ministry of Health, Malaysia

    collaborator OTHER_GOV

  • Menzies School of Health Research

    lead OTHER

Principal Investigators

  • Jayaram Menon, MBBS · Sabah Ministry of Health

  • D Prabhakaran, MBBS · Sabah Ministry of Health

  • Matthew J Grigg, MBBS · Menzies School of Health Research

  • Tsin Yeo, MBBS · Menzies School of Health Research

  • Lorenz von Seidlein, MBBS · Menzies School of Health Research

  • Nicholas M Anstey, MBBS · Menzies School of Health Research

  • Ric Price, MBBS · Menzies School of Health Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Malaysia

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 NCT01708876 on ClinicalTrials.gov