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
|Condition or disease|
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:
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|
|Actual Enrollment :||576 participants|
|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|
- Opportunistic fungal co-infections. [ Time Frame: at 12 months ]Prevalence of opportunistic fungal co-infections.
- 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
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