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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03580733

Acronym

CASPER

Enrollment

448

Registered

2018-07-09

Start date

2019-01-01

Completion date

2024-12-04

Last updated

2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU Yeast Intra-abdominal Infection

Keywords

ICU, yeast intra abdominal infection, candidiasis, ß-D-glucan, caspofungin

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.

Interventions

DRUGcaspofungin antifungal therapy

caspofungin

OTHERplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
mortality	28 and 90 days	28 and 90-day mortality rate
success rate at the end of treatment	8 days	success rate at the end of treatment
slope of ß-D-glucan concentrations	8 days	slope of ß-D-glucan concentrations

Countries

France

Contacts

Primary ContactHervé Dupont, PD

dupont.herve@chu-amiens.fr33 322 087 979

Backup ContactHervé Dupont