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Artemether-lumefantrine vs Chloroquine for Uncomplicated P. Vivax Malaria in Malaysia

NCT02348788 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2017-02-01

No results posted yet for this study

Summary

Both artemether-lumefantrine and chloroquine are currently used and recommended by Malaysian Ministry of Health as blood stage treatments for non-severe P. vivax and P. knowlesi malaria. Microscopic misdiagnosis between Plasmodium species remains a large issue in Sabah, Malaysia and elsewhere. In order to facilitate potential policy change to a unified ACT guideline for all malaria species in Sabah artemether-lumefantrine needs to be evaluated for P. vivax malaria.

Preliminary data in a recently completed RCT evaluating artesunate-mefloquine vs chloroquine for P. vivax showed up to 36% P. vivax recurrence with chloroquine monotherapy by day 28 post treatment without primaquine. Based on these data blood stage chloroquine treatment failure rates should also be evaluated in the context of standard concurrent (rather than delayed) liver stage primaquine dosing, due to both its potential blood stage synergistic effect in addition to known decreased recurrence rates. As artemether-lumefantrine is one of the current first line Ministry of Health ACTs used in Sabah with a lower adverse event profile compared to artesunate-mefloquine, this was recommended as the more appropriate ACT to evaluate against chloroquine.

Conditions

  • Plasmodium Vivax Malaria Without Complication

Interventions

DRUG

Artemether-lumefantrine + Primaquine

DRUG

Chloroquine + Primaquine

Sponsors & Collaborators

  • Ministry of Health, Malaysia

    collaborator OTHER_GOV

  • Menzies School of Health Research

    lead OTHER

Principal Investigators

  • Timothy William, MBBS, FRCP · Ministry of Health, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-12-31
Completion
2017-12-31

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 NCT02348788 on ClinicalTrials.gov