NCT04372576

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

April 29, 2020

Last Update Submit

April 30, 2020

Conditions

Ventilator Associated PneumoniaCorona Virus Infection

Outcome Measures

Primary Outcomes (1)

  • 28-day all-cause mortality

    at study completion, anticipated 5 months

Secondary Outcomes (4)

  • 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

Interventions

Assessment of ventilator-associated pneumonia criteriaDIAGNOSTIC_TEST

Diagnosis of ventilator-associated pneumonia is based upon the routine daily clinical and laboratory parameters.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University

Budapest, 1085, Hungary

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedCoronavirus Infections

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 4, 2020

Study Start

April 16, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

May 4, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)