A Randomized Trial of Coartemether and Artekin for the Treatment of Uncomplicated Malaria in Papua, Indonesia.

Completed 750 enrolled Menzies School of Health Research National Health and Medical Research Council, Australia · collab National Institute of Health Research and Development, Ministry of Health Republic of Indonesia · collab Wellcome Trust · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This open randomized, parallel group, 6 week trial in two rural outpatient clinics will compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and children (\>10kg).

Timeline

Start: 2004-07
Primary completion: —
Completion: 2005-08

Outcome

Met primary endpoint

paper 43% (95% CI 38-48) for artemether-lumefantrine and 19% (14-23) for dihydroartemisinin-piperaquine (hazard ratio=3.0, 95% CI 2.2-4.1, p<0.0001) PMID 17336652 ↗

Publications

Ratcliff A, Siswantoro H, Kenangalem E, Maristela R, Wuwung RM, Laihad F, Ebsworth EP, Anstey NM, Tjitra E, Price RN. Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: an open-label randomised comparison. Lancet. 2007 Mar 3;369(9563):757-765. doi: 10.1016/S0140-6736(07)60160-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ARTENIMOL	Small molecule	—	—
Subject	Artemether	Small molecule	—	—
Subject	lumefantrine	Small molecule	—	—
Subject	piperaquine	Small molecule	—	—