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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

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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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