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

Who is this study for? Patients with ICU Yeast Intra-Abdominal Infection
What treatments are being studied? Caspofungin Antifungal Therapy
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Amiens
RECRUITING
Amiens
Contact Information
Primary
Hervé Dupont, PD
dupont.herve@chu-amiens.fr
33 322 087 979
Backup
Hervé Dupont
dupont.herve@chu-amiens.fr
33 322 087 979
Time Frame
Start Date: 2019-01-01
Estimated Completion Date: 2024-12-04
Participants
Target number of participants: 448
Treatments
Placebo_comparator: placebo
placebo
Experimental: antifungal therapy
caspofungin
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire, Amiens

This content was sourced from clinicaltrials.gov