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

• ClinicalTrials.gov Identifier: NCT04368221
• Recruitment Status: Active, not recruiting
• First Posted: April 29, 2020
• Last Update Posted: September 4, 2020
• Sponsor: Rennes University Hospital
• Information provided by (Responsible Party): Rennes University Hospital

Tracking Information

• First Submitted Date: April 24, 2020
• First Posted Date: April 29, 2020
• Last Update Posted Date: September 4, 2020
• Actual Study Start Date: May 4, 2020
• Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 28, 2020)

Opportunistic fungal co-infections. [ Time Frame: at 12 months ]

Prevalence of opportunistic fungal co-infections.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 28, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Characterization of Fungal Infections in COVID-19 Infected and Mechanically Ventilated Patients in ICU
• Official Title: Characterization of Fungal Infections in COVID-19 Infected and Mechanically Ventilated Patients in ICU
• Brief Summary: Characterization of fungal infections in COVID-19 infected and mechanically ventilated patients in ICU

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
• Study Design: Observational Model: Cohort; Time Perspective: Other
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients hospitalized in ICU for COVID-19
• Condition: Covid-19
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 3, 2020): 576
• Original Estimated Enrollment (submitted: April 28, 2020): 250
• Estimated Study Completion Date: May 2021
• Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04368221
• Other Study ID Numbers: 35RC20_8885_MY_CO_VID
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Rennes University Hospital
• Study Sponsor: Rennes University Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Rennes University Hospital
• Verification Date: September 2020