Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis

• Status: Unknown status
• Trial end date: 2021-10-04
• Target enrollment: 0
• Participant gender: All

Summary

The incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. Prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. The aim of this study is to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in ICU patients is associated with lower failure rate compared to placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire, Amiens
• Treatments: Antifungal Agents; Caspofungin; Clotrimazole; Echinocandins; Miconazole

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

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

• Immunodepression (treatment including long-term corticosteroids, anti-TNF or disease including transplant patients)

• Infected acute pancreatitis

• Ascites fluid infection