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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

448 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2024-12-04

Brief Summary

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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.

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Detailed Description

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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

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ICU Yeast Intra-abdominal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

antifungal therapy

caspofungin

Group Type EXPERIMENTAL

caspofungin antifungal therapy

Intervention Type DRUG

caspofungin

Interventions

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caspofungin antifungal therapy

caspofungin

Intervention Type DRUG

placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No