NCT03580733

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

Prospective Multicentre Randomized Double-blind Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 448 (estimated)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ICU Yeast Intra-abdominal Infection

Interventions

Type	Name	Description
DRUG	caspofungin antifungal therapy	caspofungin
OTHER	placebo	placebo

Timeline

• Start date: 2019-01-01
• Primary completion: 2024-10-04
• Completion: 2024-12-04
• First posted: 2018-07-09
• Last updated: 2024-07-10

Locations

1 site across 1 country: France