Clinical trial NCT04368221: Characterization of Fungal Infections in COVID-19 Infected and Mechanically Ventilated Patients in ICU
Official title: Characterization of Fungal Infections in COVID-19 Infected and Mechanically Ventilated Patients in ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Keywords: Invasives mycoses
aspergillosis
pneumocystosis
mucormycosis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients hospitalized in ICU for ARDS

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.

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.

Primary outcomes:
measure: Opportunistic fungal co-infections.
timeFrame: at 12 months
Secondary outcomes:
measure: Median time
timeFrame: at 12 months
measure: Time between diagnosis and targeted treatment
timeFrame: at ICU discharge, up to 1 month
measure: Preventive strategies
timeFrame: At 12 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHU de Brest
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: CHU Lyon
city: Marseille
country: France
facility: CHU Marseille
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: CHU Paris - Avicenne
city: Paris
country: France
facility: CHU Paris - Bichat
city: Paris
country: France
facility: CHU Paris - HEGP
city: Paris
country: France
facility: CHU Paris - Mondor
city: Paris
country: France
facility: CHU Paris - Tenon
city: Paris
country: France
facility: Hôpital Lariboisière/ St Louis
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: CHU Rennes
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
Study officials:
References:
citation: Gangneux JP, Dannaoui E, Fekkar A, Luyt CE, Botterel F, De Prost N, Tadie JM, Reizine F, Houze S, Timsit JF, Iriart X, Riu-Poulenc B, Sendid B, Nseir S, Persat F, Wallet F, Le Pape P, Canet E, Novara A, Manai M, Cateau E, Thille AW, Brun S, Cohen Y, Alanio A, Megarbane B, Cornet M, Terzi N, Lamhaut L, Sabourin E, Desoubeaux G, Ehrmann S, Hennequin C, Voiriot G, Nevez G, Aubron C, Letscher-Bru V, Meziani F, Blaize M, Mayaux J, Monsel A, Boquel F, Robert-Gangneux F, Le Tulzo Y, Seguin P, Guegan H, Autier B, Lesouhaitier M, Pelletier R, Belaz S, Bonnal C, Berry A, Leroy J, Francois N, Richard JC, Paulus S, Argaud L, Dupont D, Menotti J, Morio F, Soulie M, Schwebel C, Garnaud C, Guitard J, Le Gal S, Quinio D, Morcet J, Laviolle B, Zahar JR, Bougnoux ME. Fungal infections in mechanically ventilated patients with COVID-19 during the first wave: the French multicentre MYCOVID study. Lancet Respir Med. 2022 Feb;10(2):180-190. doi: 10.1016/S2213-2600(21)00442-2. Epub 2021 Nov 26.