Who is sponsoring NCT03431714?

NCT03431714 is sponsored by National Institute for Medical Research, Tanzania.

What drugs are being tested in NCT03431714?

Interventions in NCT03431714: Artesunate amodiaquine.

What condition does NCT03431714 study?

NCT03431714 studies Uncomplicated Falciparum Malaria.

Is NCT03431714 still recruiting?

NCT03431714 is currently completed. Last updated 13 February 2018.

Last reviewed 2018-02-13 · How we verify

NCT03431714: GF-TES-2017

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Last updated 13 February 2018

What this trial tests

Phase 4 trial testing Artesunate amodiaquine in Uncomplicated Falciparum Malaria in 333 participants. Completed in 8 December 2017.

Timeline

14 July 2017

Primary endpoint
8 December 2017

8 December 2017

Quick facts

Lead sponsor	National Institute for Medical Research, Tanzania
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	333
Start date	14 July 2017
Primary completion	8 December 2017
Estimated completion	8 December 2017
Sites	1 location across Tanzania

Drugs / interventions tested

Artesunate amodiaquine

Conditions studied

Uncomplicated Falciparum Malaria — all drugs for Uncomplicated Falciparum Malaria →

Sponsor

National Institute for Medical Research, Tanzania

Who can join

Adults 6 Months to 10, any sex, with Uncomplicated Falciparum Malaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

High cure rates and tolerability of artesunate-amodiaquine and dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria in Kibaha and Kigoma, Tanzania.
Mandara CI, Francis F, Chiduo MG, Ngasala B, et al · · 2019 · cited 18× · PMID 30909922 · DOI 10.1186/s12936-019-2740-z

Verify or expand the search:

Other National Institute for Medical Research, Tanzania trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03431714 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute for Medical Research, Tanzania
Last refreshed: 13 February 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03431714.

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