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A randomized, double-blind, phase 2b study to investigate the efficacy, safety, tolerability and pharmacokinetics of a single-dose regimen of ferroquine with artefenomel in adults and children with uncomplicated Plasmodium falciparum malaria
AQ-13 - an investigational antimalarial drug
Funding for this research was provided by:
Medicines for Malaria Venture
Received: 22 January 2021
Accepted: 28 April 2021
First Online: 19 May 2021
: The study was approved by the relevant IECs and, where relevant, local regulatory authorities at each of the participating sites. The study was conducted at 10 sites across 6 African countries, Benin (Zinvié), Burkina Faso (Nanoro, Banfora and Niangoloko), Gabon (Libreville, Lambaréné), Kenya (Siaya, Kisumu), Mozambique (Chokwe), and Uganda (Tororo), and 4 sites in Vietnam (Binh Phuoc, Gia Lai, Khanh Hoa, Quang tri, although the last 2 sites did not randomize any patient). Participants provided written informed consent prior to inclusion. The local and national IECs that approved the study are the following: Comité National d’Ethique pour la Recherche en Santé, Cotonou, Benin (national IEC). Centre National de la Recherche Scientifique et Technologique (CNRST)—Comité d'Ethique Institutionnel, Bobo-Dioulasso, Burkina Faso (local IEC), Comité d’Ethique pour la Recherche en Santé, Ouagadougou, Burkina Faso (national IEC), Comité Institutionnel de Bioéthique, Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Ouagadougou, Burkina Faso (local IEC), Comité National d’Ethique pour la Recherche (CNER), Libreville, Gabon (national IEC), Kenya Medical Research Institute (KEMRI)—Scientific and Ethics Review Unit (SERU), Nairobi, Kenya (local IEC), Ao Comitê Nacional Bioética para a Saúde (CNBS), Maputo, Mozambique (national IEC), Makerere University, College of Health Sciences, School of Biomedical Sciences, Higher Degrees Research and Ethics Committee, Kampala, Uganda (local IEC), Ethics Committee of National Institute of Malariology, Parasitology and Entomology (NIMPE), Ha Noi, Vietnam (local IEC), National Ethics committee in Biomedical Research, Ministry of Health, Vietnam (national IEC).
: Not applicable.
: FM, MHCR, ACM, TW, FW, and DL are employed by MMV. BL is a consultant for MMV and was paid for his work on the FALCI Study. AJ, CC and RB are employed by Sanofi. AJ holds shares in the company. The other authors declare that they have no competing interests.