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

Centre Hospitalier Universitaire, Amiens

Status and phase: Enrolling; Phase 3

Conditions: ICU Yeast Intra-abdominal Infection

Treatments: Drug: caspofungin antifungal therapy; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03580733

PI2018_843_0007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 448 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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448 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Other: placebo

antifungal therapy

Experimental group

Description:

caspofungin

Treatment:

Drug: caspofungin antifungal therapy