WHO ICTRP trial
A Phase 3 Study of Rezafungin for Injection Versus the Standard Antimicrobial…
EUCTR2017-004981-85-FR · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2017-004981-85-FR |
|---|---|
| Public title | A Phase 3 Study of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing a Allogeneic Blood and Marrow Transplant |
| Scientific 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) - ReSPECT |
| Primary sponsor | Cidara Therapeutics Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;France;Canada;Spain;Belgium;Australia;Netherlands;Germany;United Kingdom;Italy |
| Conditions | Invasive Fungal Diseases in Adults undergoing Allogeneic Blood and Marrow Transplantation MedDRA version: 20.0 Level: HLGT Classification code 10017528 Term: Fungal infectious disorders System Organ Class: 10021881 - Infections and… |
| Interventions | Product Name: Rezafungin for Injection Product Code: Intravenous CD101 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Rezafungin acetate CAS Number: 1631754-41-0 Current Sponsor code: CD101… |
| Registration date | Sep 18, 2020 |
| Target size | 462 |
| Secondary IDs | CD101.IV.3.08;124401;2017-004981-85-DE |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: