Study design and objective
malaria
MALARIA, FALCIPARUM MALARIA
This Phase 2a, randomized, open-label, parallel-group study was conducted from 11th September 2018 to 6th November 2019 across seven study centres in Benin (Cotonou), Burkina Faso (Banfora and Nanoro), Gabon (Libreville and Lambaréné), Kenya (Kisumu), and Uganda (Kampala). The primary objective was to show the contribution of artefenomel to the clinical and parasitological activity of artefenomel and ferroquine in combination by analysing the exposure–response of artefenomel in patients with uncomplicated falciparum malaria. To achieve its objective, some patients would receive a sub-therapeutic dosing regimen, and this was considered in the design by using dedicated risk minimization activities, i.e., selection of a patient population at low risk of severe malaria, hospitalization for at least 48 h or longer based upon the investigator’s judgment, and administration of rescue therapy as soon as there was evidence of treatment failure or systematically on Day 29. The study protocol is provided as Additional file 