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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04368221
Acronym
MY-CO-VID
Enrollment
576
Registered
2020-04-29
Start date
2020-05-04
Completion date
2021-02-23
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19

Keywords

Invasives mycoses, aspergillosis, pneumocystosis, mucormycosis

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.

Interventions

None listed

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Opportunistic fungal co-infections.at 12 monthsPrevalence of opportunistic fungal co-infections.

Secondary

MeasureTime frameDescription
Median timeat 12 monthsDetermination 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 treatmentat ICU discharge, up to 1 monthEvaluation of the time between diagnosis and targeted treatment
Preventive strategiesAt 12 monthsNumber of proposals for evaluation of preventive strategies if necessary, because of high incidence, in terms of chemoprophylaxis and/or environmental measures

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026