Efficacy and Safety of ASAQ and PD for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania
Status:
Completed
Trial end date:
2017-12-08
Target enrollment:
Participant gender:
Summary
The World Health Organization recommends regular surveillance of antimalarial efficacy to
monitor the performance of different drugs. The Tanzanian National Malaria Control Programme
(NMCP) in collaboration with its partners have been implementing therapeutic efficacy studies
(TES) to monitor the performance of different antimalarials in the country. Most of the
studies conducted in recent years focused on artemether-lumefantrine which is the first line
antimalarial for the treatment of uncomplicated malaria in Mainland Tanzania. However, data
on the performance of other artemisinin based combination therapy (ACTs) is urgently needed
to support timely review and changes of treatment guidelines in case of drug resistance to
current regimen. This study was undertaken in the same NMCP framework to assess the efficacy
and safety of alternative ACTs used or with potential use in Tanzania. The study assessed the
efficacy and safety of artesunate-amodiaquine (ASAQ) and dihydroartemisinin-piperaquine (DP)
for the treatment of uncomplicated malaria in Tanzania. The study was undertaken at two NMCP
sentinel sites of Kibaha and Ujiji from July to December 2017.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute for Medical Research, Tanzania
Collaborators:
Muhimbili University of Health and Allied Sciences World Health Organization