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Completed

NCT Number: NCT04368221

Characterization of Fungal Infections in COVID-19 Infected and Mechanically Ventilated Patients in ICU

Characterization of fungal infections in COVID-19 infected and mechanically ventilated patients in ICU

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ICU patients COVID-19 diagnosed by RT-PCR
  • Intubated and mechanically ventilated patients
  • Adult patients
  • Patients (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, 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.

Treatment and study plan

Primary outcomes

  1. Opportunistic fungal co-infections.

    Time frame: at 12 months

    Prevalence of opportunistic fungal co-infections.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: MY-CO-VID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2020
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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