Characterization of Fungal Infections in COVID-19 Infected and Mechanically Ventilated Patients in ICU

Study Overview
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Brief Summary
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Characterization of fungal infections in COVID-19 infected and mechanically ventilated patients in ICU

Detailed Description
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Currently, ICU patients with ARDS, whatever the etiology, are not systematically screened for the detection of respiratory fungal infections. Here, the protocol will be in two steps: First step COVID-19 patients hospitalized in ICU for ARDS will benefit for a systematic screening with a fungal respiratory syndromic panel once or twice a week from entry to discharge from ICU, with minimum 3 samples when discharge occurs after 15 days:: Sample: tracheal aspiration, bronchial aspiration, BAL Fungal respiratory panel: samples will be processed in each lab for culture without direct examination nor stained smears, and real-time PCR will be performed for Aspergillus, Pneumocystis jirovecii and mucormycetes Results will be given to ICU in order to optimize the management of the patient Second step Complementary analysis will be performed in order to finalize the diagnostic and to differentiate between colonization and infection, with: Serum detection of galactomannan and serum Aspergillus PCR in case of positive respiratory sample for Aspergillus Serum/plasma beta-D-glucan detection in case of positive respiratory sample for Pneumocystis jirovecii Serum mucorales PCR in case of positive respiratory sample for mucorales This second step is possible in most of the labs, but when necessary a confirmation test can be externalized. A process of DNA transmission to a reference lab within each region will be implemented. This second step will allow to classify infections as probable or proven according to international recommendations. Case report form (CRF) A short but standardized CRF will be proposed to all centers in order to collect demographic data and the essential clinical and laboratory data during the survey.

Official Title
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Characterization of Fungal Infections in COVID-19 Infected and Mechanically Ventilated Patients in ICU

Conditions
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Covid-19

Participation Criteria
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Eligibility Criteria
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Inclusion criteria : ICU patients COVID-19 diagnosed by RT-PCR Intubated and mechanically ventilated patients Adult patients Patients (or legal representative) informed on the research without opposition Non-inclusion criteria : Patients <18 years old People of full age who are the subject of a judicial safeguard, Exclusion criteria: Patient, or legal representative opposing the pursuit of the research Patients under judicial protection will be excluded as soon as the investigator becomes aware of their status.

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opportunistic fungal co-infections. | Prevalence of opportunistic fungal co-infections. | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time | Determination of the median time between entry in ICU and beginning of ARDS and (i) colonization and (ii) probable/proven infection with Aspergillus, Pneumocystis jirovecii and mucormycetes | at 12 months | 
| Time between diagnosis and targeted treatment | Evaluation of the time between diagnosis and targeted treatment | at ICU discharge, up to 1 month | 
| Preventive strategies | Number of proposals for evaluation of preventive strategies if necessary, because of high incidence, in terms of chemoprophylaxis and/or environmental measures | At 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Invasives mycoses, aspergillosis, pneumocystosis, mucormycosis