Two dose levels of once-weekly fosravuconazole versus daily itraconazole in combination with surgery in patients with eumycetoma in Sudan: a randomised, double-blind, phase 2, proof-of-concept superiority trial

by Fahal AH, Ahmed ES, Bakhiet SM, Bakhiet OE, Fahal LA, Mohamed AA, Mohamedelamin ESW, Bahar MEN, Attalla HY, Siddig EE, Mhmoud NA, Musa AM, van de Sande WWJ, Scherrer B, Oyieko P, Egondi TW, Onyango KO, Hata K, Chu WY, Dorlo TPC, Brüggemann RJ, Nyaoke BA, Strub-Wourgaft N, Zijlstra EE. Lancet Infectious Diseases 2024. doi: 10.1016/S1473-3099(24)00404-3

Summary: Fungal mycetoma, a highly neglected tropical disease often caused by the fungus Madurella mycetomatis, is typically treated for a minimum of 12 months, but treatment failure is frequent and can lead to amputation. In this first-ever clinical trial of fungal mycetoma treatment, the authors compared the efficacy of fosravuconazole, a synthetic antifungal repurposed for mycetoma, with standard-of-care itraconazole, in combination with surgery at 6 months for all treatment groups. In the modified intention-to-treat population (104 patients), weekly fosravuconazole had an efficacy rate of 50% in the 300 mg arm and 65% in the 200 mg arm, while the daily itraconazole 400 mg arm had an efficacy rate of 75%. All regimens were well tolerated and there were no new safety signals.

The post Two dose levels of once-weekly fosravuconazole versus daily itraconazole in combination with surgery in patients with eumycetoma in Sudan: a randomised, double-blind, phase 2, proof-of-concept superiority trial first appeared on DNDi.

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