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

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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

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.

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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





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



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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.

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
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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

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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:
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Mycoses