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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000407-16-FR

Enrollment

448

Registered

2018-11-06

Start date

2018-12-05

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intraabdominal yeast infection

Interventions

Product Name: caspofungine Pharmaceutical Form: Powder for concentrate for solution for infusion Pharmaceutical form of the placebo: Solution for solution for infusion Route of administration of the p

Eligibility

Sex/Gender

All

Inclusion criteria

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(1) -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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 298 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 149

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 ;Timepoint(s) of evaluation of this end point: 28 d	—

Measure

Time frame

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 ;Timepoint(s) of evaluation of this end point: 28 d

—

Secondary

Measure	Time frame
Secondary end point(s): 28 and 90-day success rate at the end of treatment, slope of ß-D-glucan concentrations, 28-day mortality for subgroup analysis;Timepoint(s) of evaluation of this end point: 28 and 90 d	—

Countries

France

Contacts

Public ContactAnnabelle Boussault

CHU Amiens-Picardie

boussault.annabelle@chu-amiens.fr3322088369

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026