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

March 29, 2021 updated by: Rennes University Hospital
Characterization of fungal infections in COVID-19 infected and mechanically ventilated patients in ICU

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

576

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • CHU Angers
      • Brest, France
        • CHU de Brest
      • Dijon, France
        • CHU de Dijon
      • Grenoble, France
        • CHU Grenoble
      • Lille, France
        • CHU Lille
      • Lyon, France
        • CHU Lyon
      • Marseille, France
        • CHU Marseille
      • Nantes, France
        • CHU Nantes
      • Nice, France
        • CHU de Nice
      • Paris, France
        • Hôpital Pitié-Salpétrière
      • Paris, France
        • Hôpital Necker-Enfants Malades
      • Paris, 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
      • Poitiers, France
        • CHU Poitiers
      • Rennes, France, 35033
        • CHU Rennes
      • Strasbourg, France
        • CHU Strasbourg
      • Toulouse, France
        • CHU Toulouse
      • Tours, France
        • Chu Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COVID-19 patients hospitalized in ICU for ARDS

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opportunistic fungal co-infections.
Time Frame: at 12 months
Prevalence of opportunistic fungal co-infections.
at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median time
Time Frame: 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
at 12 months
Time between diagnosis and targeted treatment
Time Frame: at ICU discharge, up to 1 month
Evaluation of the time between diagnosis and targeted treatment
at ICU discharge, up to 1 month
Preventive strategies
Time Frame: 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
At 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2020

Primary Completion (Actual)

February 23, 2021

Study Completion (Actual)

February 23, 2021

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 28, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC20_8885_MY_CO_VID

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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