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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Unknown status

CT.gov ID

NCT03580733

Collaborator

(none)

448

Enrollment

Location

Arms

33.1

Anticipated Duration (Months)

13.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ICU Yeast Intra-abdominal Infection	Drug: caspofungin antifungal therapy Other: placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

448 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Oct 4, 2021

Anticipated Study Completion Date :

Oct 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo placebo	Other: placebo placebo
Experimental: antifungal therapy caspofungin	Drug: caspofungin antifungal therapy caspofungin

Arm

Intervention/Treatment

Placebo Comparator: placebo

placebo

Other: placebo

placebo

Experimental: antifungal therapy

caspofungin

Drug: caspofungin antifungal therapy

caspofungin

Outcome Measures

Primary Outcome Measures

failure rate after the beginning of treatment [28 days]
28-day failure rate after the beginning of treatment

Secondary Outcome Measures

mortality [28 and 90 days]
28 and 90-day mortality rate
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
mortality [28 days]
28- 28 day mortality for subgroup analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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