Intravenous Artesunate for the Treatment of Severe Imported Malaria: Implementation, Efficacy, and Safety in 1391 Patients

Abstract Background Intravenous artesunate is the World Health Organization–recommended first-line treatment for severe malaria worldwide, but it still not fully licensed in Europe. Observational studies documenting its safety and efficacy imported are thus essential. Methods We prospectively collected clinical epidemiological features of 1391 artesunate-treated patients among 110 participant centers during first 7 years (2011–2017) a national program implemented by French Drug Agency. Results Artesunate became most frequent France, rising from 9.9% 2011 to 71.4% 2017. Mortality was estimated at 4.1%. Treatment failure recorded 27 patients, mutations Kelch-13 gene were observed. Main reported adverse events (AEs) anemia (136 cases), cardiac (24, including 20 episodes conduction disorders and/or arrhythmia), liver enzyme elevation (23). AEs similar general population people with human immunodeficiency virus, who overweight, or pregnant, only pregnant woman treated trimester experimented hemorrhagic miscarriage. The incidence post-artesunate–delayed hemolysis (PADH) 42.8% when specifically assessed 98-patient subgroup, associated fatal outcomes sequelae. PADH twice as European compared African origin. Conclusions rapidly deployed displayed robust benefit malaria, despite high frequency mild moderate PADH. Further explorations context importation should assess pregnancy collect rare potentially AEs.