Staging Candidiasis in ICU Patients

NCT ID: NCT01322698

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

422 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-10-07

Brief Summary

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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

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Conditions

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Candidiasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The study population

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.

Tests for candidiasis

Intervention Type BIOLOGICAL

Tests include (1) anti-candida antibody ELISA kit; (2) candida antigen ELISA kit; (3) detection of circulating 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.

Interventions

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Tests for candidiasis

Tests include (1) anti-candida antibody ELISA kit; (2) candida antigen ELISA kit; (3) detection of circulating 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurence Lachaud, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Nathalie Bourgeois, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Nîmes

Nîmes, Gard, France

Site Status

CHU de Montpellier

Montpellier, , France

Site Status

Countries

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France

References

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Larcher R, Platon L, Amalric M, Brunot V, Besnard N, Benomar R, Daubin D, Ceballos P, Rispail P, Lachaud L, Bourgeois N, Klouche K. Emerging Invasive Fungal Infections in Critically Ill Patients: Incidence, Outcomes and Prognosis Factors, a Case-Control Study. J Fungi (Basel). 2021 Apr 24;7(5):330. doi: 10.3390/jof7050330.

Reference Type RESULT
PMID: 33923333 (View on PubMed)

Other Identifiers

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2010-A00858-31

Identifier Type: OTHER

Identifier Source: secondary_id

AOI/2009/BL-01

Identifier Type: -

Identifier Source: org_study_id

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