Proof-of-Concept Superiority Trial of Fosravuconazole Versus Itraconazole for Eumycetoma in Sudan

Summary

This study is a single-center, comparative, randomized, double-blind, parallel-group, active-controlled, clinical superiority trial of Fosravuconazole versus Itraconazole combined with surgery in subjects with eumycetoma in Sudan. There will be three arms in this study: The first arm will be Fosravuconazole 300 mg weekly, the second arm will have Fosravuconazole 200 mg weekly and the control arm is the standard treatment using itraconazole 400mg daily. At 3 months time-point, interim analysis will be done and one of the study arms will be dropped according to the drop-the-loser design, based on efficacy or toxicity.

Timeline

Start

2017-05-09

Primary completion

2021-06-10

Completion

2022-03-07

Publications

• Chu WY, Fahal AH, Ahmed ES, Bakhiet SM, Bakhiet OE, Fahal LA, Mohamed AA, Mohamedelamin ESW, Bahar MEN, Attalla HY, Siddig EE, Mhmoud NA, Musa AM, Oyieko P, Egondi T, Bruggemann RJ, Hata K, Strub-Wourgaft N, Alves F, Nyaoke BA, Zijlstra EE, Dorlo TPC. Pharmacokinetics and Pharmacodynamics of Fosravuconazole, Itraconazole, and Hydroxyitraconazole in Sudanese Patients With Eumycetoma. J Infect Dis. 2025 Sep 15;232(3):e518-e528. doi: 10.1093/infdis/jiaf279.
• 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, Bruggemann RJ, Nyaoke BA, Strub-Wourgaft N, Zijlstra EE. 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. Lancet Infect Dis. 2024 Nov;24(11):1254-1265. doi: 10.1016/S1473-3099(24)00404-3. Epub 2024 Aug 1.

Drugs

Indications