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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menzies School of Health Research
• Collaborator: Ministry of Health, Malaysia
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Chloroquine; Chloroquine diphosphate; Lumefantrine; Primaquine

Criteria

Inclusion Criteria:

• Male and female patients at least 1 year of age and weighing more than 10kg

• Microscopic diagnosis of P. vivax monoinfection

• Negative P. falciparum malaria rapid diagnostic test (histidine-rich-protein 2)

• Fever (temperature ≥37.5°C) or history of fever in the last 48 hours

• Written informed consent to participate in trial

Exclusion Criteria:

• Clinical or laboratory criteria for severe malaria, including warning signs, according to modified WHO 2010 criteria

• Parasitaemia > 100,000 /μL

• Pregnancy or lactation

• Known hypersensitivity or allergy to study drugs

• Serious underlying disease (cardiac, renal or hepatic)

• Received anti-malarials in previous 2 months

• History of psychiatric illness, epilepsy, or cerebral malaria