NCT03431714

Efficacy and Safety of ASAQ and PD for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania

Efficacy and Safety of Artesunate-amodiaquine and Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: National Institute for Medical Research, Tanzania · Other Government
• Sex: All
• Age: 6 Months – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uncomplicated Falciparum Malaria

Interventions

Type	Name	Description
DRUG	Artesunate amodiaquine	Drugs were administered under observation of the study nurse for three days

Timeline

• Start date: 2017-07-14
• Primary completion: 2017-12-08
• Completion: 2017-12-08
• First posted: 2018-02-13
• Last updated: 2018-02-13

Locations

1 site across 1 country: Tanzania