Staging Candidiasis in ICU Patients

Candidiasis Clinical Trial

Official title:

Staging Candidiasis in ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322698
• Other study ID #: AOI/2009/BL-01
• Secondary ID: 2010-A00858-31
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: March 26, 2015
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Candidiasis

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier Cedex 05
France	CHU de Nîmes	Nimes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	2 days	No
Secondary	Patient leaves ICU unit, yes/no		1 month	No
Secondary	Patient passes away in ICU unit, yes/no		1 month	No
Secondary	Patient has been prescribed an antifungal treatment in the past month, yes/no		1 month	No