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

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.

Study Overview

• Status: Recruiting
• Conditions: ICU Yeast Intra-abdominal Infection
• Intervention / Treatment: Other: placebo; Drug: caspofungin antifungal therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 448
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hervé Dupont, PD; Phone Number: 33 322 087 979; Email: dupont.herve@chu-amiens.fr
• Study Contact Backup: Name: Herve Dupont; Phone Number: 33 322 087 979; Email: dupont.herve@chu-amiens.fr

Study Locations

• France
  • Amiens, France
    • Recruiting
    • CHU Amiens
    • Contact: Herve Dupont; Phone Number: 33 322 087 979; Email: dupont.herve@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Other: placebo; placebo
Experimental: antifungal therapy; caspofungin	Drug: caspofungin antifungal therapy; caspofungin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
failure rate after the beginning of treatment	28-day failure rate after the beginning of treatment	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	28 and 90-day mortality rate	28 and 90 days
success rate at the end of treatment	success rate at the end of treatment	8 days
slope of ß-D-glucan concentrations	slope of ß-D-glucan concentrations	8 days
mortality	28- 28 day mortality for subgroup analysis	28 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): October 4, 2023
• Study Completion (Anticipated): October 4, 2023

Study Registration Dates

• First Submitted: June 8, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: candidiasis; ICU; caspofungin; yeast intra abdominal infection; ß-D-glucan
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Candidiasis; Intraabdominal Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Caspofungin; Antifungal Agents; Clotrimazole; Miconazole
• Other Study ID Numbers: PI2018_843_0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No