CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 123 enrolled
Drug / intervention
Artemether-lumefantrine combination +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02001012
NCT02001012Phase 3Completed

Artemether-lumefantrine vs Chloroquine in Patients With Acute Uncomplicated P. Knowlesi Malaria: a Randomized Open Label Trial in Sabah, Malaysia (CAN KNOW Trial)

Menzies School of Health Research·interventional·Posted Dec 4, 2013·Updated Jul 7, 2017

In Brief

A Phase 3 clinical trial evaluating Artemether-lumefantrine combination and Chloroquine for Uncomplicated Knowlesi Malaria. Completed, enrolled 123 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMalaysia

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 4, 2013
Enrollment StartJan 1, 2014
Primary CompletionJan 1, 2015
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.6 years ago

Interventions

Artemether-lumefantrine combinationdrug

Chloroquinedrug