A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV … (NCT05178862) | Clinical Trial Compass
TerminatedPhase 3
A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole
Stopped: Termination is not related to safety or efficacy concerns for Ibrexafungerp. GSK's decision is to focus efforts and resources on commercialization of Ibrexafungerp for the already approved VVC and rVVC indications.
United States68 participantsStarted 2022-08-03
Plain-language summary
This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* Subject is a male or female adult ≥ 18 years of age on the day the study informed consent is signed.
* Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever \[on one occasion \> 38°C\], hypotension, or local signs of inflammation).
Key Exclusion Criteria:
* Subject has any of the following forms of invasive candidiasis at Screening:
* Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed),
* Osteomyelitis,
* Endocarditis or myocarditis,
* Meningitis, endophthalmitis, or any central nervous system infection,
* Chronic disseminated candidiasis,
* Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract,
* Patients with a sole diagnosis of mucocutaneous candidiasis, i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or Candida isolated solely from respiratory tract specimens,
* Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection,
* P…
What they're measuring
1
All-cause mortality (US FDA Only)
Timeframe: Day 30
2
Global Response at End of Treatment (EU European Medicines Agency [EMA] Only)