Staging Candidiasis in ICU Patients

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014