Antimalarial artesunate-mefloquine versus praziquantel in African children with schistosomiasis: an open-label, randomized controlled trial

Emmanuel Bottieau, Moustapha Mbow, Isabel Brosius, Clémentine Roucher, Cheikh Tidiane Gueye, Ousmane Thiam Mbodj, Babacar Thiendella Faye, Annelies De Hondt, Bart Smekens, Diana Arango, Christophe Burm, Achilleas Tsoumanis, Linda Paredis, Yven Van Herrewege, Idzi Potters, Joachim Richter, Anna Rosanas-Urgell, Badara Cissé, Souleymane Mboup, Katja Polman

Research output: Contribution to journalA1: Web of Science-articlepeer-review


Schistosomiasis treatment entirely relies on a single drug, praziquantel, prompting research into alternative therapeutics. Here we evaluated the efficacy and safety of the antimalarial combination artesunate-mefloquine for the treatment of schistosomiasis in a proof-of-concept, pragmatic, open-label, randomized controlled trial in primary schools of six villages endemic for schistosomiasis in northern Senegal. Children (6-14 years) were eligible if Schistosoma eggs were detected by microscopy in urine and/or stool. In total, 726 children were randomized 1:1 to praziquantel (standard care: 40 mg kg -1 single dose; n = 364) or to artesunate-mefloquine (antimalarial dosage: artesunate 4 mg kg -1 and mefloquine 8 mg kg -1 daily for three consecutive days; n = 362). Eight children not meeting the inclusion criteria were excluded from efficacy analysis. Median age of the remaining 718 participants was 9 years; 399 (55.6%) were male, and 319 (44.4%) female; 99.3% were infected with Schistosoma haematobium and 15.2% with S. mansoni. Primary outcomes were cure rate, assessed by microscopy, and frequency of drug-related adverse effects of artesunate-mefloquine versus praziquantel at 4 weeks after treatment. Cure rate was 59.6% (208/349) in the artesunate-mefloquine arm versus 62.1% (211/340) in the praziquantel arm. The difference of -2.5% (95% confidence interval (CI) -9.8 to 4.8) met the predefined criteria of noninferiority (margin set at 10%). All drug-related adverse events were mild or moderate, and reported in 28/361 children receiving artesunate-mefloquine (7.8%; 95% CI 5.4 to 11.0) versus 8/363 (2.2%; 95% CI 1.1 to 4.3) receiving praziquantel (P < 0.001). Artesunate-mefloquine at antimalarial dosage was moderately safe and noninferior to standard-care praziquantel for the treatment of schistosomiasis, predominantly due to S. haematobium. Multicentric trials in different populations and epidemiological settings are needed to confirm these findings. identifier: NCT03893097 .

Original languageEnglish
JournalNature Medicine
Pages (from-to)130-137
Publication statusPublished - 2024


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