Rezafungin vs Standard Antimicrobial Regimen to stop Fungal Diseases

• Research type

  Research Study

• Full 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)

• IRAS ID

  279097

• Contact name

  Varun Mehra

• Contact email

  Varun.Mehra@nhs.net

• Sponsor organisation

  Cidara Therapeutics Inc.

• Eudract number

  2017-004981-85

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT00000000

• Duration of Study in the UK

  1 years, 6 months, 31 days

• Research summary

  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.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  20/NW/0187

• Date of REC Opinion

  23 Apr 2020

• REC opinion

  Favourable Opinion