Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368221
Recruitment Status : Active, not recruiting
First Posted : April 29, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Characterization of fungal infections in COVID-19 infected and mechanically ventilated patients in ICU

Condition or disease
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Opportunistic fungal co-infections. [ Time Frame: at 12 months ]
    Prevalence of opportunistic fungal co-infections.


Secondary Outcome Measures :
  1. 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

  2. Time between diagnosis and targeted treatment [ Time Frame: at ICU discharge, up to 1 month ]
    Evaluation of the time between diagnosis and targeted treatment

  3. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in ICU for COVID-19
Criteria

Inclusion criteria :

  • ICU patients COVID-19 diagnosed by RT-PCR
  • Intubated and mechanically ventilated patients
  • Adult patients
  • Patients (or family 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, relative 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368221


Locations
Show Show 22 study locations
Sponsors and Collaborators
Rennes University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04368221    
Other Study ID Numbers: 35RC20_8885_MY_CO_VID
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
Invasives mycoses
aspergillosis
pneumocystosis
mucormycosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Mycoses