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

Medientyp: E-Artikel
Titel: Antimalarial artesunate–mefloquine versus praziquantel in African children with schistosomiasis: an open-label, randomized controlled trial
Beteiligte: Bottieau, Emmanuel; Mbow, Moustapha; Brosius, Isabel; Roucher, Clémentine; Gueye, Cheikh Tidiane; Mbodj, Ousmane Thiam; Faye, Babacar Thiendella; De Hondt, Annelies; Smekens, Bart; Arango, Diana; Burm, Christophe; Tsoumanis, Achilleas; Paredis, Linda; Van Herrewege, Yven; Potters, Idzi; Richter, Joachim; Rosanas-Urgell, Anna; Cissé, Badara; Mboup, Souleymane; Polman, Katja
Erschienen: Springer Science and Business Media LLC, 2024
Erschienen in: Nature Medicine
Sprache: Englisch
DOI: 10.1038/s41591-023-02719-4
ISSN: 1078-8956; 1546-170X
Schlagwörter: General Biochemistry, Genetics and Molecular Biology ; General Medicine
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Beschreibung: <jats:title>Abstract</jats:title><jats: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 <jats:italic>Schistosoma</jats:italic> 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<jats:sup>−1</jats:sup> single dose; <jats:italic>n</jats:italic> = 364) or to artesunate–mefloquine (antimalarial dosage: artesunate 4 mg kg<jats:sup>−1</jats:sup> and mefloquine 8 mg kg<jats:sup>−1</jats:sup> daily for three consecutive days; <jats:italic>n</jats:italic> = 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 <jats:italic>Schistosoma haematobium</jats:italic> and 15.2% with <jats:italic>S. mansoni</jats:italic>. 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 (<jats:italic>P</jats:italic> < 0.001). Artesunate–mefloquine at antimalarial dosage was moderately safe and noninferior to standard-care praziquantel for the treatment of schistosomiasis, predominantly due to <jats:italic>S. haematobium</jats:italic>. Multicentric trials in different populations and epidemiological settings are needed to confirm these findings. ClinicalTrials.gov identifier: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/study/NCT03893097">NCT03893097</jats:ext-link>.</jats:p>

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