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

ICU Yeast Intra-abdominal Infection Clinical Trial

— CASPER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03580733
• Other study ID #: PI2018_843_0007
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2019
• Est. completion date: October 4, 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Hervé Dupont, PD
• Phone: 33 322 087 979
• Email: dupont.herve[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 448
• Est. completion date: October 4, 2023
• Est. primary completion date: October 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• ICU Yeast Intra-abdominal Infection
• Intraabdominal Infections

Intervention

Drug:
• caspofungin antifungal therapy
caspofungin

Other:
• placebo
placebo

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	failure rate after the beginning of treatment	28-day failure rate after the beginning of treatment	28 days
Secondary	mortality	28 and 90-day mortality rate	28 and 90 days
Secondary	success rate at the end of treatment	success rate at the end of treatment	8 days
Secondary	slope of ß-D-glucan concentrations	slope of ß-D-glucan concentrations	8 days
Secondary	mortality	28- 28 day mortality for subgroup analysis	28 days