drugset / Trial / NCT04368559
Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen.
Timeline
- Start
- 2020-05-11
- Primary completion
- 2026-01-29
- Completion
- 2026-01-29
Publications
- Cross SJ, Wolf J, Patel PA. Prevention, Diagnosis and Management of Pneumocystis jirovecii Infection in Children With Cancer or Receiving Hematopoietic Cell Therapy. Pediatr Infect Dis J. 2023 Dec 1;42(12):e479-e482. doi: 10.1097/INF.0000000000004102. Epub 2023 Sep 21. No abstract available.
- Ham YY, Lewis JS 2nd, Thompson GR 3rd. Rezafungin: a novel antifungal for the treatment of invasive candidiasis. Future Microbiol. 2021 Jan;16(1):27-36. doi: 10.2217/fmb-2020-0217.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluconazole | Small molecule | 400 mg | Oral |
| Comparator | Posaconazole | Small molecule | 300 mg | Oral |
| Subject | Rezafungin | Other / unclassified | 200 mg | Intravenous |
| Comparator | trimethoprim-sulfamethoxazole | Unknown | 80 mg | Oral |
| Comparator | trimethoprim-sulfamethoxazole | Unknown | 400 mg | Oral |