The Diagnosis of Superinfections in Mechanically Ventilated Covid-19 Patients

COVID-19 Pneumonia Clinical Trial

— SUPER-BAL  

Official title:

The Diagnosis of Superinfections in Mechanically Ventilated Covid-19 Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05148975
• Other study ID #: 145/21
• Status: Recruiting
• Start date: December 11, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: December 2021
• Source: Brno University Hospital
• Contact: Jan Hudec, MD
• Phone: +420532233850
• Email: hudec.jan[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Disagreement with the inclusion in the trial

Related Conditions & MeSH terms

• ARDS, Human
• COVID-19
• COVID-19 Pneumonia
• Pneumonia
• Respiratory Distress Syndrome

Intervention

Diagnostic Test:
• Bronchoalveolar lavage fluid diagnostics
Bronchoalveolar lavage fluid diagnostics for superinfection in patients with COVID-19 pneumonia.

Locations

Country	Name	City	State
Czechia	St. Annes University Hospital	Brno	Czech Republic
Czechia	University Hospital Brno	Brno	Czech Republic

Sponsors (2)

Lead Sponsor	Collaborator
Brno University Hospital	St. Anne's University Hospital Brno, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superinfection incidence	The incidence and characteristics of superinfections in patients with Coronavirus Disease 2019 (COVID-19).	1 year
Secondary	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.	1 year
Secondary	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.	1 year