MY-CO-VID: Characterization of Fungal Infections in COVID-19 Infected and Mechanically Ventilated Patients in ICU

Sponsor

Rennes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04368221

Collaborator

(none)

576

Enrollment

Locations

9.7

Actual Duration (Months)

26.2

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid-19

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.

Study Design

Study Type:

Observational

Actual Enrollment :

576 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

May 4, 2020

Actual Primary Completion Date :

Feb 23, 2021

Actual Study Completion Date :

Feb 23, 2021

Outcome Measures

Primary Outcome Measures

Opportunistic fungal co-infections. [at 12 months]
Prevalence of opportunistic fungal co-infections.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU Angers	Angers	France
2	CHU de Brest	Brest	France
3	CHU de Dijon	Dijon	France
4	CHU Grenoble	Grenoble	France
5	CHU Lille	Lille	France
6	CHU Lyon	Lyon	France
7	CHU Marseille	Marseille	France
8	CHU Nantes	Nantes	France
9	CHU de Nice	Nice	France
10	CHU Paris - Avicenne	Paris	France
11	CHU Paris - Bichat	Paris	France
12	CHU Paris - HEGP	Paris	France
13	CHU Paris - Mondor	Paris	France
14	CHU Paris - Tenon	Paris	France
15	Hôpital Lariboisière/ St Louis	Paris	France
16	Hôpital Necker-Enfants Malades	Paris	France
17	Hôpital Pitié-Salpêtrière	Paris	France
18	CHU Poitiers	Poitiers	France
19	CHU Rennes	Rennes	France	35033
20	CHU Strasbourg	Strasbourg	France
21	CHU Toulouse	Toulouse	France
22	CHU Tours	Tours	France