Clinical trial NCT03580733: Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
Official title: Prospective Multicentre Randomized Double-blind Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: ICU Yeast Intra-abdominal Infection
Keywords: ICU
yeast intra abdominal infection
candidiasis
ß-D-glucan
caspofungin
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: failure rate after the beginning of treatment
timeFrame: 28 days
Secondary outcomes:
measure: mortality
timeFrame: 28 and 90 days
measure: success rate at the end of treatment
timeFrame: 8 days
measure: slope of ß-D-glucan concentrations
timeFrame: 8 days
measure: mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References: