Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and Vietnam
Status:
Completed
Trial end date:
2020-03-04
Target enrollment:
Participant gender:
Summary
This study is a multi-centre, open-label randomised trial to assess the efficacy, safety and
tolerability of the Triple ACT artemether-lumefantrine+amodiaquine (AL+AQ) compared to the
ACT artemether-lumefantrine (AL) in uncomplicated falciparum malaria in Cambodia and Vietnam.
The estimated total sample size is 600 patients from 2 sites in Cambodia and 2 sites in
Vietnam. There are 2 treatment arms Arm 1: Artemether-lumefantrine for 3 days Arm 2:
Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days. According to the World Health
Organization guideline, all patients except children under 10 kilograms will also be treated
with a single dose of primaquine as a gametocytocidal treatment.
Funder :Bill & Melinda Gates Foundation (BMGF) Grant reference number: OPP1132628