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

• Sponsor: Semmelweis University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04372576
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 3.5
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ventilator Associated Pneumonia; Corona Virus Infection	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 Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Epidemiology and Outcome of Ventilator-associated Pneumonia Among Critically Ill COVID-19 Patients
• Actual Study Start Date: Apr 16, 2020
• Anticipated Primary Completion Date: Aug 1, 2020
• Anticipated Study Completion Date: Aug 1, 2020

Outcome Measures

Primary Outcome Measures

1. 28-day all-cause mortality [at study completion, anticipated 5 months]

Secondary Outcome Measures

1. Days of mechanical ventilation [average time frame expected 2-3 weeks]

2. ICU length-of-stay [average time frame expected 3-4 weeks]

3. Antibiotic utilization [average time frame expected 3-4 weeks (at discharge from ICU)]

4. Ventilator-associated pneumonia rate [at study completion, anticipated 5 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Semmelweis University	Budapest		Hungary	1085

Sponsors and Collaborators

• Semmelweis University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zsolt Iványi, Associate Professor, Semmelweis University
• ClinicalTrials.gov Identifier: NCT04372576
• Other Study ID Numbers: 57/2020.
• First Posted: May 4, 2020
• Last Update Posted: May 4, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated; Coronavirus Infections

Study Results

No Results Posted as of May 4, 2020