clinical trial · NCT04368559
Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
Mundipharma Research Limited·phase3·completed·n = 602
CandidemiaMycosesFungal InfectionFungemiaInvasive CandidiasisPneumocystisMold InfectionInvasive Fungal DiseaseRezafungin for InjectionPosaconazoleFluconazoleTrimethoprim-sulfamethoxazole (TMP/SMX)Intravenous PlaceboOral Placebo
brief 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.
started
May 11, 2020
primary completion
Jan 29, 2026
completion
Jan 29, 2026
last updated
Apr 13, 2026
detailed description
A Phase 3, multicenter, prospective, randomized, double-blind, efficacy and safety study of Rezafungin for injection versus the standard antimicrobial regimen for the prevention of invasive fungal diseases in subjects undergoing allogeneic blood and marrow transplantation.
official title
A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol