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Completed

NCT Number: NCT01322698

Staging Candidiasis in ICU Patients

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.

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Key information

Conditions

Candidiasis Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes, Nîmes, Gard, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tests for candidiasis

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.

Primary outcomes

  1. Number of positive Candidiasis tests

    Time frame: 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 outcomes

  1. Number of positive Candidiasis tests

    Time frame: 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.

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 25, 2011
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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