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P. Knowlesi Trial of Artemether-lumefantrine vs Chloroquine

NCT02001012 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2017-07-07

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 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. We are currently conducting a separate RCT using a similar protocol evaluating artesunate-mefloquine versus chloroquine for uncomplicated P. knowlesi malaria. However artemether-lumefantrine should also be compared against chloroquine due to the fact it is also a first line anti-malarial recommended in Malaysia, and there are potential differences in efficacy due to the different administration, absorption and half-life of artemether-lumefantrine.

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 infection in both adults and children in this region.

Conditions

  • Uncomplicated Knowlesi Malaria

Interventions

DRUG

Artemether-lumefantrine combination

DRUG

Chloroquine

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

  • Matthew Grigg, MBBS · Menzies School of Health Research

  • Prabakaran Dhanaraj, MBBS · Sabah Ministry of Health

  • Tsin Yeo, MBBS · Menzies School of Health Research

  • Bridget Barber, MBBS · Menzies School of Health Research

  • Nicholas 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
2014-01-31
Primary Completion
2015-01-31
Completion
2015-03-31

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 NCT02001012 on ClinicalTrials.gov