Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT03580733

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Amiens

Amiens, France

Actively Recruiting

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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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