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

Corona Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04372576
• Other study ID #: 57/2020.
• Status: Recruiting
• Start date: April 16, 2020
• Est. completion date: August 2020

Study information

• Verified date: April 2020
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Pneumonia
• Pneumonia, Ventilator-Associated
• Severe Acute Respiratory Syndrome
• Ventilator Associated Pneumonia
• Virus Diseases

Intervention

Diagnostic Test:
• Assessment of ventilator-associated pneumonia criteria
Diagnosis of ventilator-associated pneumonia is based upon the routine daily clinical and laboratory parameters.

Locations

Country	Name	City	State
Hungary	Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day all-cause mortality		at study completion, anticipated 5 months
Secondary	Days of mechanical ventilation		average time frame expected 2-3 weeks
Secondary	ICU length-of-stay		average time frame expected 3-4 weeks
Secondary	Antibiotic utilization		average time frame expected 3-4 weeks (at discharge from ICU)
Secondary	Ventilator-associated pneumonia rate		at study completion, anticipated 5 months