by Kande Betu Kumesu V, Mutombo Kalonji W, Bardonneau C, Valverde Mordt O, Tete D, Blesson S, Simon F, Delhomme S, Bernhard S, Nganzobo Ngima P, Mahenzi Mbembo H, Fina Lubaki JP, Lumeya Vuvu S, Kuziena Mindele W, Ilunga Wa Kyhi M, Mandula Mokenge G, Kaninda Badibabi L, Kasongo Bonama A, Kavunga Lukula P, Lumbala C, Scherrer B, Strub-Wourgaft N, Tarral A. The Lancet Global Health 2022, 10(11): e1665-1674. doi: 10.1016/S2214-109X(22)00338-2
Summary: This single-arm, open-label, phase 2/3 trial assessed the safety and efficacy of fexinidazole in children with sleeping sickness caused by Trypanosoma brucei gambiense (g-HAT). This plug-in to the pivotal trial was conducted in the Democratic Republic of the Congo in 125 children with any stage of g-HAT (69 with stage 1, 19 with early stage 2, and 37 with late stage 2). The treatment success rate at 12 months was 97.6%, exceeding the targeted value of 92% (98.6% for stage 1, 94.7% for early stage 2, and 97.3% for late stage 2). No new safety issues were observed and the authors conclude that fexinidazole is a safe and effective first-line treatment option for all stages of g-HAT in paediatric patients.