Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin followed by Oral Ibrexafungerp versus Intravenous Echinocandin followed by Oral Fluconazole

Phase 1

• Conditions: Invasive Candidiasis/ Candidemia; MedDRA version: 20.0Level: LLTClassification code: 10060573Term: Candidemia Class: 10021881; MedDRA version: 20.0Level: LLTClassification code: 10064954Term: Invasive candidiasis Class: 10021881; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2024-511755-18-00
• Lead Sponsor: Scynexis Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-13
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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 within ± 4 days (96 hours) of initiation of IV echinocandin accompanied by any related clinical sign and/or symptom (e.g., fever [on one occasion > 38°C], hypotension, or local signs of inflammation, etc.).

Exclusion Criteria

Subject has any of the following forms of invasive candidiasis at Screening: a. Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed), b. Osteomyelitis, c. Endocarditis or myocarditis, d. Meningitis, endophthalmitis, or any central nervous system infection, e. Chronic disseminated candidiasis, f. Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract, g. 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, h. Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection, i. Patients who failed a previous antifungal therapy for the same infection, j. Subject has an uncontrolled 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. Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible., Baseline QTcF = 500 msec, history or family history of Torsades de Pointes or other conditions that would put the subject at undue risk for development of ventricular arrythmias (including Torsades de Pointes).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified