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Staging Candidiasis in ICU Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01322698
First Posted: March 25, 2011
Last Update Posted: March 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
  Purpose
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.

Condition Intervention
Candidiasis Biological: Tests for candidiasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Staging Candidiasis in ICU Patients

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • Patient leaves ICU unit, yes/no [ Time Frame: 1 month ]
  • Patient passes away in ICU unit, yes/no [ Time Frame: 1 month ]
  • Patient has been prescribed an antifungal treatment in the past month, yes/no [ Time Frame: 1 month ]

Biospecimen Retention:   Samples With DNA
Serum sample

Enrollment: 422
Study Start Date: October 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322698


Locations
France
CHU de Nîmes
Nimes, Gard, France, 30029
CHU de Montpellier
Montpellier Cedex 05, France, 34090
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Study Director: Laurence Lachaud, MD Centre Hospitalier Universitaire de Nîmes
Principal Investigator: Nathalie Bourgeois, MD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01322698     History of Changes
Other Study ID Numbers: AOI/2009/BL-01
2010-A00858-31 ( Other Identifier: RCB number )
First Submitted: March 24, 2011
First Posted: March 25, 2011
Last Update Posted: March 27, 2015
Last Verified: March 2015

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
ICU

Additional relevant MeSH terms:
Candidiasis
Mycoses