NCT01322698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
422

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2014

Completed
Last Updated

November 17, 2025

Status Verified

March 1, 2015

Enrollment Period

3 years

First QC Date

March 24, 2011

Last Update Submit

November 14, 2025

Conditions

Candidiasis

Keywords

ICU

Outcome Measures

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.

    7 days

Secondary Outcomes (4)

  • Number of positive Candidiasis tests

    2 days

  • 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

Study Arms (1)

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

Tests for candidiasisBIOLOGICAL

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.

The study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Nîmes

Nîmes, Gard, 30029, France

Location

CHU de Montpellier

Montpellier, 34090, France

Location

Related Publications (1)

  • 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.

    PMID: 33923333RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum sample

MeSH Terms

Conditions

Candidiasis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Officials

  • Laurence Lachaud, MD

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR

  • Nathalie Bourgeois, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2011

First Posted

March 25, 2011

Study Start

October 1, 2011

Primary Completion

October 7, 2014

Study Completion

October 7, 2014

Last Updated

November 17, 2025

Record last verified: 2015-03

Locations

FR(2)