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Staging Candidiasis in ICU Patients

Staging Candidiasis in ICU Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01322698
Enrollment
422
Registered
2011-03-25
Start date
2011-10-31
Completion date
2014-10-07
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidiasis

Keywords

ICU

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.

Interventions

BIOLOGICALTests 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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of positive Candidiasis tests7 daysNumber 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

MeasureTime frameDescription
Number of positive Candidiasis tests2 daysNumber 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/no1 month
Patient passes away in ICU unit, yes/no1 month
Patient has been prescribed an antifungal treatment in the past month, yes/no1 month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026