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

Phase 3

Recruiting

• Conditions: ICU Yeast Intra-abdominal Infection
• Interventions: Other: placebo; Drug: caspofungin antifungal therapy

• Registration Number: NCT03580733
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

Detailed Description

The incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. These infections are clearly associated with increased morbidity and mortality in both community-acquired and healthcare-associated infections. So far,prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. No prospective randomized trial has been conducted on intra-abdominal candidiasis and most retrospective analyses have reported very conflicting results concerning the impact of treatment on outcome. The aim of this study is therefore to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in ICU patients is associated with lower failure rate compared to placebo.

Study Timeline

• Study First Submitted: 2018-06-08
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-07-09
• Study Start: 2019-01-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-10-04
• Study Completion: 2024-12-04

Recruitment & Eligibility

• Status: 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(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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo
antifungal therapy	caspofungin antifungal therapy	caspofungin

Primary Outcome Measures

Name	Time	Method
failure rate after the beginning of treatment	28 days	28-day failure rate after the beginning of treatment

Secondary Outcome Measures

Name	Time	Method
mortality	28 days	28- 28 day mortality for subgroup analysis
success rate at the end of treatment	8 days	success rate at the end of treatment
slope of ß-D-glucan concentrations	8 days	slope of ß-D-glucan concentrations

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France