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

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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

Tracking Information
First Submitted Date April 29, 2020
First Posted Date May 4, 2020
Last Update Posted Date May 4, 2020
Actual Study Start Date April 16, 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2020)		 28-day all-cause mortality [ Time Frame: at study completion, anticipated 5 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 30, 2020)
  • Days of mechanical ventilation [ Time Frame: average time frame expected 2-3 weeks ]
  • ICU length-of-stay [ Time Frame: average time frame expected 3-4 weeks ]
  • Antibiotic utilization [ Time Frame: average time frame expected 3-4 weeks (at discharge from ICU) ]
  • Ventilator-associated pneumonia rate [ Time Frame: at study completion, anticipated 5 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiology and Outcome of Ventilator-associated Pneumonia Among Critically Ill COVID-19 Patients
Official Title Epidemiology and Outcome of Ventilator-associated Pneumonia Among Critically Ill COVID-19 Patients
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Critically ill individuals diagnosed with PCR confirmed CoViD-19 disease requiring mechanical ventilation for > 48 hours.
Condition
  • Ventilator Associated Pneumonia
  • Corona Virus Infection
Intervention Diagnostic Test: Assessment of ventilator-associated pneumonia criteria
Diagnosis of ventilator-associated pneumonia is based upon the routine daily clinical and laboratory parameters.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 30, 2020)		 30
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Hungary
Removed Location Countries  
 
Administrative Information
NCT Number NCT04372576
Other Study ID Numbers 57/2020.
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Zsolt Iványi, Semmelweis University
Study Sponsor Semmelweis University
Collaborators Not Provided
Investigators Not Provided
PRS Account Semmelweis University
Verification Date April 2020