Epidemiology and Outcome of Ventilator-associated Pneumonia Among Critically Ill COVID-19 Patients

The aim of this study is to determine the risk factors for development of ventilator-associated pneumonia (VAP) and to identify the prognostic factors of VAP among Coronavirus Disease 2019 (CoViD-19) patients. We hypothesized that CoViD-19 serves as a high risk factor for the development of VAP and it affects clinical outcome measures negatively.

Study Overview

• Status: Unknown
• Conditions: Corona Virus Infection; Ventilator Associated Pneumonia
• Intervention / Treatment: Diagnostic test: Assessment of ventilator-associated pneumonia criteria

Detailed Description

Coronavirus Disease 2019 (CoViD-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) became a pandemic affecting thousands of individuals worldwide. A considerable proportion of CoViD-19 patients require admission to the intensive care unit (ICU), although limited data are available on their clinical characteristics and course. The results of retrospective studies indicate older age, presence of comorbidies and secondary infections as predictors of mortality among this population. Further evaluation regarding ICU clinical course and predictors of mortality is needed.

The aim of this study is to determine the risk factors for development of VAP and to identify the prognostic factors of VAP among CoViD-19 patients.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1085
    • Recruiting
    • Semmelweis University
    • Contact: Bence Mogyoródi, MD; Phone Number: +36208250801; Email: mogyorodi.bence@med.semmelweis-univ.hu

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

Critically ill individuals diagnosed with PCR confirmed CoViD-19 disease requiring mechanical ventilation for > 48 hours.

Description

Inclusion Criteria:

• Critically ill individuals diagnosed with PCR confirmed CoViD-19 disease
• Started mechanical ventilation for > 48 hours
• Informed consent signed by the patient or authorised representative

Exclusion Criteria:

• Participation in an interventional trial aiming nosocomial infections
• refused informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
28-day all-cause mortality	at study completion, anticipated 5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Days of mechanical ventilation	average time frame expected 2-3 weeks
ICU length-of-stay	average time frame expected 3-4 weeks
Antibiotic utilization	average time frame expected 3-4 weeks (at discharge from ICU)
Ventilator-associated pneumonia rate	at study completion, anticipated 5 months

Collaborators and Investigators

• Sponsor: Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Coronavirus Infections; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 57/2020.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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