Prospective multicenter randomized double-blind study comparing caspofungin to placebo for the treatment of ICU yeast intra-abdominal infectio

Phase 1

Conditions: yeast intra-abdominal infection, peritonitis
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: CTIS2024-516266-11-00

Lead Sponsor: Centre Hospitalier Universitaire Amiens Picardie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 448

Inclusion Criteria

Age = 18 years old, Covered by national health insurance, Admitted to ICU after surgery for intra-abdominal infection : - With suspected intra-abdominal candidiasis defined by a Peritonitis score = 3 - Or with documented intra-abdominal candidiasis defined by positive direct examination or positive culture of peritoneal fluid collected intraoperatively, With written and signed informed consent

Exclusion Criteria

Allergy to caspofungin, Life expectancy = 48h, Expected withdrawal of treatment, Radiological drainage without surgery, Severe hepatic impairment (Child-Pugh C score), Pregnant or lactating women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Decrease of failure rate at 28-day after the beginning of treatment in ITT analysis;Secondary Objective: Decreased crude 28 and 90-day mortality on ITT and PP analysis, Increased success rate at the end of treatment on ITT and PP analysis, Decreased serum ß-D-glucan concentration at the end of treatment, Subgroup analysis for 28-day mortality: community-acquired versus healthcare-associated infections, timing of antifungal therapy (empiric or documented), C. albicans versus C. non-albicans, septic shock versus no shock;Primary end point(s): 28-day failure rate after the beginning of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):28 and 90-day mortality;Secondary end point(s):Success rate at the end of treatment;Secondary end point(s):Slope of ß-D-glucan concentrations;Secondary end point(s):28-day mortality for subgroup analysis