@article{99393,
  keywords = {General Biochemistry, Genetics and Molecular Biology, General Medicine},
  author = {Bottieau E and Mbow M and Brosius I and Roucher C and Gueye CT and Mbodj OT and Faye BT and De Hondt A and Smekens B and Arango D and Burm C and Tsoumanis A and Paredis L and Van Herrewege Y and Potters I and Richter J and Rosanas-Urgell A and Cissé B and Mboup S and Polman K},
  title = {Antimalarial artesunate–mefloquine versus praziquantel in African children with schistosomiasis: an open-label, randomized controlled trial},
  abstract = {<p>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 &lt; 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. ClinicalTrials.gov identifier: NCT03893097.</p>
},
  year = {2024},
  journal = {Nature Medicine},
  pages = {1-14},
  publisher = {Springer Science and Business Media LLC},
  issn = {1078-8956, 1546-170X},
  url = {https://www.nature.com/articles/s41591-023-02719-4.pdf},
  doi = {10.1038/s41591-023-02719-4},
  language = {Eng},
}