COVID-19 and VA-LRTI: Second Versus First Wave of the Pandemic

NCT05256511 | Unknown

• 1 other identifier: HLJ_2022_01
• Study Type: observational
• Target: 1,136
• Locations: 1 country
• Sites: 1

Brief Summary

Multicenter observational retrospective cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients from the first and the second wave of the pandemic.

Conditions

Severe COVID-19

Keywords

SARS-CoV-2; ventilator-associated tracheobronchitis; ventilator-associated pneumonia; bacterial co-infection; COVID-associated pulmonary aspergillosis

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of ventilator-associated lower respiratory tract infection (ventilator-associated pneumonia and ventilator associated tracheobronchitis)

  from day 3 of mechanical ventilation to extubation or day 28 post-intubation

Secondary Outcomes (8)

• Cumulative incidence of ventilator-associated tracheobronchitis

  from day 3 of mechanical ventilation to extubation or day 28 post-intubation

• Cumulative incidence of ventilator-associated pneumonia

  from day 3 of mechanical ventilation to extubation or day 28 post-intubation

• Prevalence of early bacterial coinfection

  from day 0 to day 2 of mechanical ventilation

• Cumulative incidence of COVID-associated pulmonary aspergillosis

  from day 3 of mechanical ventilation to extubation or day 28 post-intubation

• ICU mortality

  at day 28

Study Arms (2)

SARS-CoV-2 first wave

Patients with confirmed SARS-CoV-2 infection and receiving invasive mechanical ventilation for more than 48h, in the first wave of the pandemic, starting on 01-01-2020

SARS-CoV-2 second wave

Patients with confirmed SARS-CoV-2 infection and receiving invasive mechanical ventilation for more than 48h, in the second wave of the pandemic, starting on 10-01-2020

Eligibility Criteria

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

Study Population

Patients with confirmed SARS-CoV-2 community-acquired pneumonia and receiving invasive mechanical ventilation for more than 48h in the participating ICUs from the start of COVID pandemic are eligible for this study.

You may qualify if:

• Major (18 years and older)
• Admitted to the ICU
• Intubated and mechanically ventilated for more than 48 hours
• With a confirmed community-acquired SARS-CoV2 pneumonia

You may not qualify if:

• Refusal to participate
• Lack of social security coverage

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Salengro - Hopital B Chr Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saad NSEIR, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saad NSEIR, MD,PhD

CONTACT

0320445962; Saadalla.NSEIR@CHRU-LILLE.FR

Anahita ROUZE, MD

CONTACT

anahita.rouze@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: February 25, 2022
• Study Start: November 15, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-02

Locations

FR (1)