Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
CASPER
Prospective Multicentre Randomized Double-blind Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
1 other identifier
interventional
448
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2019
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2018
CompletedFirst Posted
Study publicly available on registry
July 9, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2024
CompletedJuly 10, 2024
July 1, 2024
5.8 years
June 8, 2018
July 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
failure rate after the beginning of treatment
28-day failure rate after the beginning of treatment
28 days
Secondary Outcomes (4)
mortality
28 and 90 days
success rate at the end of treatment
8 days
slope of ß-D-glucan concentrations
8 days
mortality
28 days
Study Arms (2)
placebo
PLACEBO COMPARATORplacebo
antifungal therapy
EXPERIMENTALcaspofungin
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2018
First Posted
July 9, 2018
Study Start
January 1, 2019
Primary Completion
October 4, 2024
Study Completion
December 4, 2024
Last Updated
July 10, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share