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CompletedNCT01322698Updated Nov 17, 2025

Staging Candidiasis in ICU Patients

An observational study in Candidiasis, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
422
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Candidiasis

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Keywords

  • ICU
03

In context

Candidiasis

132 studies on the registry are indexed under Candidiasis; 9 are open to participants now.

This study's enrollment of 422 is above the median of 162 across 39 observational studies indexed under Candidiasis.

Browse Candidiasis studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
422 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    Biological: Tests for candidiasis

Interventions

  • BiologicalTests 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.

06

What researchers measure

Primary outcomes

  1. Number of positive Candidiasis tests

    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.

    Time frame: 7 days

Secondary outcomes

  1. Number of positive Candidiasis tests

    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.

    Time frame: 2 days

  2. Patient leaves ICU unit, yes/no

    Time frame: 1 month

  3. Patient passes away in ICU unit, yes/no

    Time frame: 1 month

  4. Patient has been prescribed an antifungal treatment in the past month, yes/no

    Time frame: 1 month

07

Study locations

2 sites
  • CHU de Nîmes
    Nîmes, Gard 30029, France
  • CHU de Montpellier
    Montpellier, 34090, France
08

References and documents

Publications

  • 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. PubMed 33923333 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01322698
Responsible party
Sponsor
First posted
Mar 25, 2011
Start date
Oct 2011
Primary completion
Oct 7, 2014
Completion
Oct 7, 2014
Last update
Nov 17, 2025

Study contacts

Laurence Lachaud, MD
study director · Centre Hospitalier Universitaire de Nīmes
Nathalie Bourgeois, MD
principal investigator · Centre Hospitalier Universitaire de Nīmes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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