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

Autor: Bottieau E; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium. ebottieau@itg.be., Mbow M; Institute for Health Research, Epidemiological Surveillance and Training (IRESSEF), Dakar, Senegal.; Department of Immunology, Cheikh Anta Diop University, Dakar, Senegal., Brosius I; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium., Roucher C; Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium., Gueye CT; Institute for Health Research, Epidemiological Surveillance and Training (IRESSEF), Dakar, Senegal., Mbodj OT; Institute for Health Research, Epidemiological Surveillance and Training (IRESSEF), Dakar, Senegal., Faye BT; Institute for Health Research, Epidemiological Surveillance and Training (IRESSEF), Dakar, Senegal., De Hondt A; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium., Smekens B; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium., Arango D; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium., Burm C; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium., Tsoumanis A; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium., Paredis L; Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium., Van Herrewege Y; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium., Potters I; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium., Richter J; Institute of Tropical Medicine and International Health, Charité Universitätsmedizin, Berlin, Germany., Rosanas-Urgell A; Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium., Cissé B; Institute for Health Research, Epidemiological Surveillance and Training (IRESSEF), Dakar, Senegal., Mboup S; Institute for Health Research, Epidemiological Surveillance and Training (IRESSEF), Dakar, Senegal., Polman K; Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.; Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
Jazyk: angličtina
Zdroj: Nature medicine [Nat Med] 2024 Jan; Vol. 30 (1), pp. 130-137. Date of Electronic Publication: 2024 Jan 04.
DOI: 10.1038/s41591-023-02719-4
Abstrakt: 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. ClinicalTrials.gov identifier: NCT03893097 .
(© 2024. The Author(s).)
Databáze: MEDLINE
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