Clinical Trial: Staging Candidiasis in ICU Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Staging Candidiasis in ICU Patients

Brief 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.

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Nīmes

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nīmes

Dates:
Date Received: March 24, 2011
Date Started: October 2011
Date Completion:
Last Updated: March 26, 2015
Last Verified: March 2015