Staging Candidiasis in ICU Patients

Completed

• Conditions: Candidiasis
• Interventions: Biological: Tests for candidiasis

• Registration Number: NCT01322698
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

Our primary objective is to evaluate the relevance of the early determination of Candida infection status among non-neutropenic patients hospitalized over 48 hours in ICUs.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Study Start: 2011-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 422

Inclusion Criteria

• Polynuclear neutrophils > 500/mm^3
• Hospitalized for > 48 hours in participating ICUs

Exclusion Criteria

• Patients discharged from ICU in < 48h
• Patient diagnosed with invasive candidosis before entry to ICU
• Patient is taking an anti-fungal treatment
• polynuclear neutrophils < 500/mm^3
• patient transferred to another ICU
• patient included in the Abmidex protocole

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The study population	Tests for candidiasis	The target population includes patients in ICUs at the Nîmes and Montpellier University hospitals. This is a population of non-neutropenic patients (polynuclear neutrophils \> 500/mm3) at risk of developing invasive candidiasis.

Primary Outcome Measures

Name	Time	Method
Number of positive Candidiasis tests	7 days	Number of tests (score of 0 to 4) positive for Candida. Tests include (1) anti-candida antibody ELISA kit; (2) candida antigen ELISA kit; (3) detection of ciruclating Candida DNA via SYBR Breen qPCR Master mix; (4) colonization index based on mycological examination of five out of the following: urine, oral swab, bronchial aspirate, anal swab, swab of a central venous line, gastric liquid.

Secondary Outcome Measures

Name	Time	Method
Number of positive Candidiasis tests	2 days	Number of tests (score of 0 to 4) positive for Candida. Tests include (1) anti-candida antibody ELISA kit; (2) candida antigen ELISA kit; (3) detection of ciruclating Candida DNA via SYBR Breen qPCR Master mix; (4) colonization index based on mycological examination of five out of the following: urine, oral swab, bronchial aspirate, anal swab, swab of a central venous line, gastric liquid.
Patient leaves ICU unit, yes/no	1 month
Patient passes away in ICU unit, yes/no	1 month
Patient has been prescribed an antifungal treatment in the past month, yes/no	1 month

Trial Locations

Locations (2)

CHU de Nîmes; 🇫🇷 Nimes, Gard, France

CHU de Montpellier; 🇫🇷 Montpellier Cedex 05, France