A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

Launched by SCYNEXIS, INC. · Dec 16, 2021

Keywords

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Gender

ALL

Eligibility criteria

• 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,
• • Patients who failed a previous antifungal therapy for the same infection,
• • Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive candidiasis.
• • Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 10-fold the upper limit of normal (ULN).
• • Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score \> 9).
• • Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin.
• • o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.
• • Baseline QTcF ≥ 500 msec.