Staging Candidiasis in ICU Patients

Study Overview
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Brief Summary
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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.

Official Title
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Staging Candidiasis in ICU Patients

Conditions
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Candidiasis

Intervention / Treatment
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* Biological: Tests for candidiasis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The study population<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Patient leaves ICU unit, yes/no |  | 1 month | 
| Patient passes away in ICU unit, yes/no |  | 1 month | 
| Patient has been prescribed an antifungal treatment in the past month, yes/no |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU