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

Characterization of fungal infections in COVID-19 infected and mechanically ventilated patients in ICU

Detailed Description

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.

Completed
COVID-19
Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

CHU Angers
Angers, France

CHU de Brest
Brest, France

CHU de Dijon
Dijon, France

CHU Grenoble
Grenoble, France

CHU Lille
Lille, France

CHU Lyon
Lyon, France

CHU Marseille
Marseille, France

CHU Nantes
Nantes, France

CHU de Nice
Nice, France

CHU Paris - Avicenne
Paris, France

CHU Paris - Bichat
Paris, France

CHU Paris - HEGP
Paris, France

CHU Paris - Mondor
Paris, France

CHU Paris - Tenon
Paris, France

Hôpital Lariboisière/ St Louis
Paris, France

Hôpital Necker-Enfants Malades
Paris, France

Hôpital Pitié-Salpêtrière
Paris, France

CHU Poitiers
Poitiers, France

CHU Rennes
Rennes, France

CHU Strasbourg
Strasbourg, France

CHU Toulouse
Toulouse, France

CHU Tours
Tours, France

Rennes University Hospital
NCT Number
Keywords
Invasives mycoses
aspergillosis
pneumocystosis
mucormycosis
MeSH Terms
COVID-19
Mycoses