Actively Recruiting
Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2024-07-10
448
Participants Needed
1
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 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 2 3
- Or with documented intra-abdominal candidiasis defined by positive direct examination or positive culture of peritoneal fluid collected intraoperatively
- Provided written and signed informed consent
You will not qualify if you...
- Allergy to caspofungin
- Life expectancy 2 48 hours
- Expected withdrawal of treatment
- Radiological drainage without surgery
- Severe hepatic impairment (Child-Pugh C score)
- Pregnant or lactating women
- Immunodepression including long-term corticosteroids, anti-TNF treatment, or diseases including transplant patients
- Infected acute pancreatitis
- Ascites fluid infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU Amiens
Amiens, France
Actively Recruiting
Research Team
H
Hervé Dupont, PD
CONTACT
H
Hervé Dupont
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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