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

Study Overview
=================
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.

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

Conditions
-----------------
ICU Yeast Intra-abdominal Infection

Intervention / Treatment
-----------------
* Drug: caspofungin antifungal therapy
* Other: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo | Other: placebo<br>* placebo<br>|
| Experimental: antifungal therapy<br>caspofungin | Drug: caspofungin antifungal therapy<br>* caspofungin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure rate after the beginning of treatment | 28-day failure rate after the beginning of treatment | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | 28 and 90-day mortality rate | 28 and 90 days | 
| success rate at the end of treatment | success rate at the end of treatment | 8 days | 
| slope of ß-D-glucan concentrations | slope of ß-D-glucan concentrations | 8 days | 
| mortality | 28- 28 day mortality for subgroup analysis | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU, yeast intra abdominal infection, candidiasis, ß-D-glucan, caspofungin