drugset / Trial / NCT02348788

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

NCT02348788

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Artemether Small molecule 20 mg
Comparator Artemether Small molecule 40 mg
Comparator Artemether Small molecule 60 mg
Comparator Chloroquine Small molecule 5 mg/kg
Comparator Chloroquine Small molecule 310 mg
Comparator lumefantrine Small molecule 120 mg
Comparator lumefantrine Small molecule 240 mg
Comparator lumefantrine Small molecule 360 mg
Comparator Primaquine Small molecule 0.5 mg/kg
Comparator Primaquine Small molecule 30 mg