Characterization of Fungal Infections in COVID-19 Infected and Mechanically Ventilated Patients in ICU
- Conditions
- Covid-19
- Registration Number
- NCT04368221
- Lead Sponsor
- Rennes University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 576
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Opportunistic fungal co-infections. at 12 months Prevalence of opportunistic fungal co-infections.
- Secondary Outcome Measures
Name Time Method Median time at 12 months 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
Time between diagnosis and targeted treatment at ICU discharge, up to 1 month Evaluation of the time between diagnosis and targeted treatment
Preventive strategies At 12 months Number of proposals for evaluation of preventive strategies if necessary, because of high incidence, in terms of chemoprophylaxis and/or environmental measures
Trial Locations
- Locations (22)
CHU Angers
🇫🇷Angers, France
CHU Grenoble
🇫🇷Grenoble, France
CHU Lille
🇫🇷Lille, France
CHU de Nice
🇫🇷Nice, France
CHU Paris - Avicenne
🇫🇷Paris, France
CHU Nantes
🇫🇷Nantes, France
CHU Paris - Bichat
🇫🇷Paris, France
CHU Paris - HEGP
🇫🇷Paris, France
CHU Paris - Mondor
🇫🇷Paris, France
Hôpital Necker-Enfants Malades
🇫🇷Paris, France
CHU Rennes
🇫🇷Rennes, France
Hôpital Lariboisière/ St Louis
🇫🇷Paris, France
Hôpital Pitié-Salpêtrière
🇫🇷Paris, France
CHU Toulouse
🇫🇷Toulouse, France
CHU de Brest
🇫🇷Brest, France
CHU de Dijon
🇫🇷Dijon, France
CHU Lyon
🇫🇷Lyon, France
CHU Paris - Tenon
🇫🇷Paris, France
CHU Poitiers
🇫🇷Poitiers, France
CHU Strasbourg
🇫🇷Strasbourg, France
CHU Tours
🇫🇷Tours, France
CHU Marseille
🇫🇷Marseille, France