Staging Candidiasis in ICU Patients

This study is currently recruiting participants.
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01322698
First received: March 24, 2011
Last updated: March 4, 2014
Last verified: March 2014
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Patient passes away in ICU unit, yes/no [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Patient has been prescribed an antifungal treatment in the past month, yes/no [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum sample


Estimated Enrollment: 432
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322698

Contacts
Contact: Laurence M Lachaud, MD +33.(0)4.66.68.33.73 laurence.lachaud@chu-nimes.fr
Contact: Carey M Suehs, PhD 33466686788 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes Recruiting
Nimes, Gard, France, 30029
Sub-Investigator: Jean Yves Lefrant, MD PhD         
Sub-Investigator: Laurent Muller, MD         
Principal Investigator: Laurence Lachaud, MD         
Sub-Investigator: Nathalie Bourgeois, MD         
CHU de Montpellier Recruiting
Montpellier Cedex 05, France, 34090
Sub-Investigator: Philippe Rispail, MD         
Sub-Investigator: Patrick Bastien, MD PhD         
Sub-Investigator: Samir Jaber, MD PhD         
Sub-Investigator: Gérald Chanques, MD         
Sub-Investigator: Boris Jung, MD         
Sub-Investigator: Bruno Souche, MD         
Sub-Investigator: Daniel Verzilli, MD         
Sub-Investigator: Nans Rossel, MD         
Sub-Investigator: Pablo Massanet, MD         
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

No publications provided

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
Study First Received: March 24, 2011
Last Updated: March 4, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
ICU

Additional relevant MeSH terms:
Candidiasis
Mycoses

ClinicalTrials.gov processed this record on April 22, 2014