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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04372576
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Zsolt Iványi, Semmelweis University

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
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.

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Study Type : Observational
Estimated 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 : April 16, 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020



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


Primary Outcome Measures :
  1. 28-day all-cause mortality [ Time Frame: at study completion, anticipated 5 months ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill individuals diagnosed with PCR confirmed CoViD-19 disease requiring mechanical ventilation for > 48 hours.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372576


Locations
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Hungary
Semmelweis University Recruiting
Budapest, Hungary, 1085
Contact: Bence Mogyoródi, MD    +36208250801    mogyorodi.bence@med.semmelweis-univ.hu   
Sponsors and Collaborators
Semmelweis University
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Responsible Party: Zsolt Iványi, Associate Professor, Semmelweis University
ClinicalTrials.gov Identifier: NCT04372576    
Other Study ID Numbers: 57/2020.
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Cross Infection
Infection
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections