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)
Recipient organisationNIHR Cambridge Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodFeb 2025 — Feb 2026
In plain English
AI plain-English summary
A bone marrow transplant leaves patients with dangerously low white blood cell counts, making them vulnerable to invasive fungal infections that can spread through the body and kill them. This phase 3 clinical trial tests whether a new drug called rezafungin can prevent those infections better than the current standard regimen of fluconazole, posaconazole, and trimethoprim/sulfamethoxazole. The study will enroll 462 patients worldwide—54 in the UK—who are receiving allogeneic bone marrow transplants for blood cancers or aplastic anaemia. Each participant will be followed for up to 141 days. If rezafungin proves safer or more effective, it could become the new standard of care for preventing a complication that currently carries a serious risk of death. The trial also measures how much rezafungin remains in the blood over time, which will help doctors determine the right dosing schedule. This is a practical, patient-focused trial with a clear endpoint: fewer fatal fungal infections in people whose immune systems have been temporarily wiped out by transplant treatment.
View original technical description
The purposes of this study are to:• Learn if rezafungin is safe and tolerable compared to the standard treatment.• Learn if rezafungin is effective in preventing IFD compared to the standard treatment.• Find out how much rezafungin is in patient's blood over time after study drug has been given.One common side effect of an allogeneic Bone Marrow Transplant (BMT) treatment is a decrease in the number or strength of white blood cells, whose function is to fight infections. When white blood cell numbers are low or the cells are weak, the body cannot fight infections. One type of opportunistic infection that is possible in BMT patients is called invasive fungal disease (IFD), a type of fungal infection that has the ability to spread throughout the body and result in serious risk of death. In this study, rezafungin will be compared with the currently approved drugs for preventing IFD. The currently approved drugs are referred to as the standard antimicrobial regimen (SAR). The SAR in this study is fluconazole, with the option of switching to posaconazole based on changes in patient's medical condition and at the discretion of the study doctor. SAR also includes oral trimethoprim/sulfamethoxazole, usually given for prevention of other opportunistic infections (Pneumocystis). Some of the main inclusion criteria are the following: • Willing and able to provide written informed consent.• Males or Females over the age of 18 years old. • Receiving myeloablative or reduced-intensity conditioning regimens for BMT using related or unrelated voluntary donors.• Diagnosed with one of the Haematological malignancies or Aplastic Anaemia needing allogeneic BMT.This study will invite the participation of approximately 462 participants worldwide and 54 participants in the UK .The study will be conducted in hospitals. The study is expected to last up to 141 days, including the screening period of up to 14 days.
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