The Diagnosis of Superinfections in Mechanically Ventilated Covid-19 Patients (SUPER-BAL)

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19 Pneumonia; ARDS, Human; Superinfection
• Intervention / Treatment: Diagnostic test: Bronchoalveolar lavage fluid diagnostics

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Jan Hudec, MD; Phone Number: +420532233850; Email: hudec.jan@fnbrno.cz
• Study Contact Backup: Name: Jan Maláska, MD, Ph.D.; Phone Number: +420532233850; Email: malaska.jan@fnbrno.cz

Study Locations

• Czechia
  • Czech Republic
    • Brno, Czech Republic, Czechia, 62500
      • Recruiting
      • University Hospital Brno
      • Contact: Jan Hudec, MD; Phone Number: +420532233850; Email: hudec.jan@fnbrno.cz
      • Contact: Jan Maláska, MD, Ph.D.; Phone Number: +420532233850; Email: malaska.jan@fnbrno.cz
      • Principal Investigator: Jan Hudec, MD
    • Brno, Czech Republic, Czechia, 65691
      • Not yet recruiting
      • St. Annes University Hospital
      • Contact: Pavel Suk, MD, Ph.D.; Phone Number: +420543183537; Email: pavel.suk@fnusa.cz
      • Principal Investigator: Pavel Suk, MD, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with COVID-19 ARDS on mechanical ventilation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Bronchoalveolar lavage fluid diagnostics; Bronchoalveolar lavage fluid diagnostics for superinfection in patients with COVID-19 pneumonia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superinfection incidence	The incidence and characteristics of superinfections in patients with Coronavirus Disease 2019 (COVID-19).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Collaborators: St. Anne's University Hospital Brno, Czech Republic

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 11, 2021
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): March 31, 2023

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (ACTUAL): December 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; ARDS; pneumonia; bronchoalveolar lavage; superinfection
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Lung Diseases; Parasitic Diseases; Opportunistic Infections; COVID-19; Pneumonia; Respiratory Distress Syndrome; Superinfection; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Dimercaprol
• Other Study ID Numbers: 145/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No