search
Back to results

Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis (CASPER)

Primary Purpose

ICU Yeast Intra-abdominal Infection

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
caspofungin antifungal therapy
placebo
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ICU Yeast Intra-abdominal Infection focused on measuring ICU, yeast intra abdominal infection, candidiasis, ß-D-glucan, caspofungin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

antifungal therapy

Arm Description

placebo

caspofungin

Outcomes

Primary Outcome Measures

failure rate after the beginning of treatment
28-day failure rate after the beginning of treatment

Secondary Outcome Measures

mortality
28 and 90-day mortality rate
success rate at the end of treatment
success rate at the end of treatment
slope of ß-D-glucan concentrations
slope of ß-D-glucan concentrations
mortality
28- 28 day mortality for subgroup analysis

Full Information

First Posted
June 8, 2018
Last Updated
May 9, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
search

1. Study Identification

Unique Protocol Identification Number
NCT03580733
Brief Title
Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
Acronym
CASPER
Official Title
Prospective Multicentre Randomized Double-blind Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
October 4, 2023 (Anticipated)
Study Completion Date
October 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICU Yeast Intra-abdominal Infection
Keywords
ICU, yeast intra abdominal infection, candidiasis, ß-D-glucan, caspofungin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
448 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
antifungal therapy
Arm Type
Experimental
Arm Description
caspofungin
Intervention Type
Drug
Intervention Name(s)
caspofungin antifungal therapy
Intervention Description
caspofungin
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
failure rate after the beginning of treatment
Description
28-day failure rate after the beginning of treatment
Time Frame
28 days
Secondary Outcome Measure Information:
Title
mortality
Description
28 and 90-day mortality rate
Time Frame
28 and 90 days
Title
success rate at the end of treatment
Description
success rate at the end of treatment
Time Frame
8 days
Title
slope of ß-D-glucan concentrations
Description
slope of ß-D-glucan concentrations
Time Frame
8 days
Title
mortality
Description
28- 28 day mortality for subgroup analysis
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hervé Dupont, PD
Phone
33 322 087 979
Email
dupont.herve@chu-amiens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hervé Dupont
Phone
33 322 087 979
Email
dupont.herve@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herve Dupont
Phone
33 322 087 979
Email
dupont.herve@chu-amiens.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis

We'll reach out to this number within 24 hrs