A Study by the Tracking Resistance to Artemisinin Collaboration (TRAC)
Status:
Completed
Trial end date:
2018-03-01
Target enrollment:
Participant gender:
Summary
This study is an open-label randomised trial comparing standard ACT treatment with matching
triple artemisinin-based combination therapies (TACTs), evaluating efficacy in safety and
tolerability. The estimated total sample size is 2040 patients from 16 sites in Asia and 1
site in Africa. There are 2 arm study groups that have 2 treatment arms each.
Study group A:
A.1: Artemether-lumefantrine for 3 days. versus: A.2: Artemether-lumefantrine for 3 days plus
Amodiaquine for 3 days.
Study group B:
B.1: Dihydroartemisinin-piperaquine for 3 days. versus: B.2: Dihydroartemisinin-piperaquine
for 3 days plus Mefloquine hydrochloride for 3 days.
Study group C:
C.1: Artesunate-mefloquine for 3 days versus: C.2: Dihydroartemisinin-piperaquine for 3 days
plus Mefloquine hydrochloride for 3 days.
According to the WHO guideline, all patients except for children under the age of 1 year or a
weight below 10 kilograms will also be treated with a single dose of low dose primaquine.