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Covid-19MY-CO-VIDNCT04368221

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

An observational study of Covid-19, run by Rennes University Hospital at 22 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Characterization of fungal infections in COVID-19 infected and mechanically ventilated patients in ICU Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid-19
How many people
576 participants
Where
22 sitesFrance
Study dates
4 May 2020to 23 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: COVID-19 patients hospitalized in ICU for ARDS

Who may be able to join

  • 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,

Who cannot join

  • 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

France22 sites

  • CHU Angers

    Angers

  • CHU de Brest

    Brest

  • CHU de Dijon

    Dijon

  • CHU Grenoble

    Grenoble

  • CHU Lille

    Lille

  • CHU Lyon

    Lyon

  • CHU Marseille

    Marseille

  • CHU Nantes

    Nantes

  • CHU de Nice

    Nice

  • CHU Paris - Avicenne

    Paris

  • CHU Paris - Bichat

    Paris

  • CHU Paris - HEGP

    Paris

  • CHU Paris - Mondor

    Paris

  • CHU Paris - Tenon

    Paris

  • Hôpital Lariboisière/ St Louis

    Paris

  • Hôpital Necker-Enfants Malades

    Paris

  • Hôpital Pitié-Salpêtrière

    Paris

  • CHU Poitiers

    Poitiers

  • CHU Rennes

    Rennes, 35033

  • CHU Strasbourg

    Strasbourg

  • CHU Toulouse

    Toulouse

  • CHU Tours

    Tours

Other trials in France

About this study

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

Read the 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.

Conditions
Covid-19
Keywords
Invasives mycoses, aspergillosis, pneumocystosis, mucormycosis
Medical subject headings
COVID-19, Aspergillosis, Pneumonia, Pneumocystis, Mucormycosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opportunistic fungal co-infections.

    Prevalence of opportunistic fungal co-infections.

    Measured: at 12 months

Secondary outcomes (3)

  1. Median time

    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

    Measured: at 12 months

  2. Time between diagnosis and targeted treatment

    Evaluation of the time between diagnosis and targeted treatment

    Measured: at ICU discharge, up to 1 month

  3. Preventive strategies

    Number of proposals for evaluation of preventive strategies if necessary, because of high incidence, in terms of chemoprophylaxis and/or environmental measures

    Measured: At 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2020
  2. Study start4 May 2020
  3. Primary completion23 Feb 2021
  4. Study completion23 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
576 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04368221
Sponsor's protocol ID
35RC20_8885_MY_CO_VID
Acronym
MY-CO-VID
Status last verified
Mar 2021
First submitted
24 Apr 2020
Last updated
30 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gangneux JP, Dannaoui E, Fekkar A, Luyt CE, Botterel F, De Prost N, Tadie JM, Reizine F, Houze S, Timsit JF, Iriart X, Riu-Poulenc B, Sendid B, Nseir S, Persat F, Wallet F, Le Pape P, Canet E, Novara A, Manai M, Cateau E, Thille AW, Brun S, Cohen Y, Alanio A, Megarbane B, Cornet M, Terzi N, Lamhaut L, Sabourin E, Desoubeaux G, Ehrmann S, Hennequin C, Voiriot G, Nevez G, Aubron C, Letscher-Bru V, Meziani F, Blaize M, Mayaux J, Monsel A, Boquel F, Robert-Gangneux F, Le Tulzo Y, Seguin P, Guegan H, Autier B, Lesouhaitier M, Pelletier R, Belaz S, Bonnal C, Berry A, Leroy J, Francois N, Richard JC, Paulus S, Argaud L, Dupont D, Menotti J, Morio F, Soulie M, Schwebel C, Garnaud C, Guitard J, Le Gal S, Quinio D, Morcet J, Laviolle B, Zahar JR, Bougnoux ME. Fungal infections in mechanically ventilated patients with COVID-19 during the first wave: the French multicentre MYCOVID study. Lancet Respir Med. 2022 Feb;10(2):180-190. doi: 10.1016/S2213-2600(21)00442-2. Epub 2021 Nov 26.

    PubMed 34843666

Questions about this trial

What is this clinical trial studying?

An observational study of Covid-19, run by Rennes University Hospital at 22 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opportunistic fungal co-infections. (time frame: at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04368221, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.

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