COVID-19 PneumoniaSUPER-BALNCT05148975
The Diagnosis of Superinfections in Mechanically Ventilated Covid-19 Patients
An observational study of COVID-19 Pneumonia and Superinfection, run by Brno University Hospital at 2 sites in Czechia.
Trial summary
Patients with severe Coronavirus Disease 2019 (Covid-19) pneumonia depending on mechanical ventilation are at risk of superinfections, especially infections of respiratory tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, Superinfection, ARDS, Human
- What is being tested?
- Bronchoalveolar lavage fluid diagnostics
- How many people
- 150 participants
- Where
- 2 sitesCzechia
- Study dates
- 11 Dec 2021to 31 Mar 2023
- 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: Adults with COVID-19 ARDS on mechanical ventilation.
Who may be able to join
- Age > 18 years
- 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
Who cannot join
- Disagreement with the inclusion in the trial
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Recruiting
University Hospital Brno
Brno, Czech Republic, 62500
Jan Hudec, MD, +420532233850, hudec.jan@fnbrno.cz
Jan Maláska, MD, Ph.D., +420532233850, malaska.jan@fnbrno.cz
- Not yet recruiting
St. Annes University Hospital
Brno, Czech Republic, 65691
Pavel Suk, MD, Ph.D., +420543183537, pavel.suk@fnusa.cz
Pavel Suk, MD, Ph.D.
About this study
Patients with severe Coronavirus Disease 2019 (Covid-19) pneumonia depending on mechanical ventilation are at risk of superinfections, especially infections of respiratory tract. This multicententer prospective observational study is focused on early diagnosis of respiratory tract superinfections and identification of risk factors (immunosuppressive therapy,...). Investigators will use bronchoalveolar lavage fluid (BALF) for Polymerase Chain Reaction (PCR) detection of pathogens and antigenic detection of mycoses.
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.
Read the detailed description
Prospective, observational multicenter study
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
- COVID-19 Pneumonia, Superinfection, ARDS, Human
- Being tested
- Bronchoalveolar lavage fluid diagnostics
- Keywords
- COVID-19, pneumonia, superinfection, bronchoalveolar lavage, ARDS
- Medical subject headings
- Superinfection, Respiratory Distress Syndrome, COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoalveolar lavage fluid diagnosticsDiagnostic test
Bronchoalveolar lavage fluid diagnostics for superinfection in patients with COVID-19 pneumonia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Bronchoalveolar lavage fluid diagnostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superinfection incidence
The incidence and characteristics of superinfections in patients with Coronavirus Disease 2019 (COVID-19).
Measured: 1 year
Secondary outcomes (2)
The aasociation inflammation diagnostic values and the diagnosis of superinfection
Markers of infection / inflammation diagnostic values for the diagnosis of a specific type of superinfection.
Measured: 1 year
The differention of superinfection diagnosis between historical cohort and actual cohort.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start11 Dec 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic
- Responsible party
- Principal investigator, Jan Hudec, MD, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148975
- Sponsor's protocol ID
- 145/21
- Acronym
- SUPER-BAL
- Status last verified
- Dec 2021
- First submitted
- 2 Dec 2021
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnosis of Superinfections in Mechanically Ventilated Covid-19 Patients
- ClinicalTrials.gov ID
- NCT05148975
- Acronym / sponsor ID
- SUPER-BAL / 145/21
- Conditions
- COVID-19 Pneumonia, Superinfection, ARDS, Human
- Keywords
- COVID-19, pneumonia, superinfection, bronchoalveolar lavage, ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic
- Study start
- 11 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with severe Coronavirus Disease 2019 (Covid-19) pneumonia depending on mechanical ventilation are at risk of superinfections, especially infections of respiratory tract. This multicententer prospective observational study is focused on early diagnosis of respiratory tract superinfections and identification of risk factors (immunosuppressive therapy,...). Investigators will use bronchoalveolar lavage fluid (BALF) for Polymerase Chain Reaction (PCR) detection of pathogens and antigenic detection of mycoses.
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
Prospective, observational multicenter study
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild ARDS due to Covid- 19 pneumonia | – | Diagnostic Test: Bronchoalveolar lavage fluid diagnosticsAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with COVID-19 ARDS on mechanical ventilation.
Key inclusion criteria (5 listed)
- Age > 18 years
- 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
Key exclusion criteria (1 listed)
- Disagreement with the inclusion in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoalveolar lavage fluid diagnosticsBronchoalveolar lavage fluid diagnostics for superinfection in patients with COVID-19 pneumonia. | Diagnostic test | Mild ARDS due to Covid- 19 pneumonia |
Primary outcome
Superinfection incidence
Time frame: 1 year
The incidence and characteristics of superinfections in patients with Coronavirus Disease 2019 (COVID-19).
2 secondary outcomes
The aasociation inflammation diagnostic values and the diagnosis of superinfection
Time frame: 1 year
The differention of superinfection diagnosis between historical cohort and actual cohort.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and Superinfection, run by Brno University Hospital at 2 sites in Czechia.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Hudec, MD (+420532233850, hudec.jan@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superinfection incidence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2021.