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

Covid-19 Clinical Trial

— MY-CO-VID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04368221
• Other study ID #: 35RC20_8885_MY_CO_VID
• Status: Completed
• Start date: May 4, 2020
• Est. completion date: February 23, 2021

Study information

• Verified date: March 2021
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 576
• Est. completion date: February 23, 2021
• Est. primary completion date: February 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19
• Mycoses

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opportunistic fungal co-infections.	Prevalence of opportunistic fungal co-infections.	at 12 months
Secondary	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
Secondary	Time between diagnosis and targeted treatment	Evaluation of the time between diagnosis and targeted treatment	at ICU discharge, up to 1 month
Secondary	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