The Diagnosis of Superinfections in Mechanically Ventilated Covid-19 Patients

NCT05148975 | Unknown

• 1 other identifier: 145/21
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

COVID-19 Pneumonia; Superinfection; ARDS, Human

Keywords

COVID-19; pneumonia; superinfection; bronchoalveolar lavage; ARDS

Outcome Measures

Primary Outcomes (1)

• Superinfection incidence

  The incidence and characteristics of superinfections in patients with Coronavirus Disease 2019 (COVID-19).

  1 year

Secondary Outcomes (2)

• The aasociation inflammation diagnostic values and the diagnosis of superinfection

  1 year

• The differention of superinfection diagnosis between historical cohort and actual cohort.

  1 year

Study Arms (1)

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

Interventions

Bronchoalveolar lavage fluid diagnostics DIAGNOSTIC_TEST

Bronchoalveolar lavage fluid diagnostics for superinfection in patients with COVID-19 pneumonia.

Mild ARDS due to Covid- 19 pneumonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with COVID-19 ARDS on mechanical ventilation.

You may qualify if:

• 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

Sponsors & Collaborators

• Brno University Hospital: lead
• St. Anne's University Hospital Brno, Czech Republic: collaborator

Study Sites (2)

University Hospital Brno

Brno, Czech Republic, 62500, Czechia

RECRUITING

St. Annes University Hospital

Brno, Czech Republic, 65691, Czechia

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Part of the sample from bronchoalveolar lavage fluid (BALF) will be frozen for possible further analysis.

MeSH Terms

Conditions

Superinfection; Respiratory Distress Syndrome; COVID-19; Pneumonia

Condition Hierarchy (Ancestors)

Opportunistic Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Central Study Contacts

Jan Hudec, MD

CONTACT

+420532233850; hudec.jan@fnbrno.cz

Jan Maláska, MD, Ph.D.

CONTACT

+420532233850; malaska.jan@fnbrno.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 8, 2021
• Study Start: December 11, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: December 27, 2021

Record last verified: 2021-12

Locations

CZ (2)