The Diagnosis of Superinfections in Mechanically Ventilated Covid-19 Patients
NCT ID: NCT05148975
Last Updated: 2021-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2021-12-11
2023-03-31
Brief Summary
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This project can support the routine use of BALF and PCR diagnostics for early detection of pathogens. Data will be compared with historical cohort of patients without routine BAL.
Detailed Description
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The inclusion criteria are as follows:
Age \> 18 years Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) PCR positivity in the last 21 days Mechanical ventilation for Covid-19 pneumonia Presence of lung infiltrations on the chest X-ray or ground glass opacity, crazy paving or lung infiltrations on the chest CT Oxygenation disorder according to Acute Respiratory Distress Syndrome (ARDS) definition: Partial Pressure of Oxygen in Arterial Blood (PaO2) / fraction of inspired oxygen (FiO2) \<300 mmHg with positive end expiratory pressure (PEEP) at least 5 cmH2O
The exclusion criteria are as follows:
Disagreement with the inclusion in the trial
Outcomes Primary outcome: incidence and characteristics of superinfections in patients with Covid-19.
Secondary outcome:
Markers of infection/inflammation diagnostic values for the diagnosis of a specific type of superinfection.
Comparison of the incidence of bacterial and opportunistic superinfections with a historical cohort, where the extension of diagnostics with bronchoalveolar lavage was performed only in patients who did not respond to antibacterial therapy
Size of the group of patients The number of patients enrolled in the study depends on the epidemiological situation and the number of admitted patients with severe Covid-19 disease. Investigators expect that the University Hospital at St. Anne's enrolls 75 patients and the University Hospital Brno also enrolls 75 patients. The size of the group is not relevant due to character of the study.
Monitored parameters Bronchoalveolar lavage (BAL) is the only procedure that differs from standard care. It is usually performed in patients with a suspected lung infection that does not respond to antibiotic therapy. In the study, BAL will be performed early after admission and then in 7-day intervals ( ± 1 day). This interval can be shortened to a minimum of 3 days if there are signs of a new lung infection.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mild ARDS due to Covid- 19 pneumonia
Adults with SARS-CoV-2 PCR positivity in the last 21 days on mechanical ventilation for Covid-19 pneumonia, fulfilling criteria for mild acute respiratory distress syndrome (ARDS) definition.
Bronchoalveolar lavage fluid diagnostics
Bronchoalveolar lavage fluid diagnostics for superinfection in patients with COVID-19 pneumonia.
Interventions
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Bronchoalveolar lavage fluid diagnostics
Bronchoalveolar lavage fluid diagnostics for superinfection in patients with COVID-19 pneumonia.
Eligibility Criteria
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Inclusion Criteria
* SARS-CoV-2 PCR positivity in the last 21 days
* Mechanical ventilation for Covid-19 pneumonia
* Presence of lung infiltrations on the chest X-ray or ground glass opacity, crazy paving or lung infiltrations on the chest CT
* Oxygenation disorder according to ARDS definition: PaO2 / FiO2 \<300 mmHg with PEEP at least 5 cmH2O
Exclusion Criteria
18 Years
ALL
No
Sponsors
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St. Anne's University Hospital Brno, Czech Republic
OTHER
Brno University Hospital
OTHER
Responsible Party
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Jan Hudec, MD
physician
Locations
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University Hospital Brno
Brno, Czech Republic, Czechia
St. Annes University Hospital
Brno, Czech Republic, Czechia
Countries
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Central Contacts
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Facility Contacts
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Jan Hudec, MD
Role: primary
Jan Maláska, MD, Ph.D.
Role: backup
Pavel Suk, MD, Ph.D.
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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145/21
Identifier Type: -
Identifier Source: org_study_id