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

Phase 1

• Conditions: intraabdominal yeast infection; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-000407-16-FR
• Lead Sponsor: CHU Amiens-Picardie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-06
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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(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

•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