Viewing Study NCT04867161



Ignite Creation Date: 2024-05-06 @ 4:04 PM
Last Modification Date: 2024-10-26 @ 2:03 PM
Study NCT ID: NCT04867161
Status: UNKNOWN
Last Update Posted: 2022-06-30
First Post: 2021-04-27

Brief Title: Superinfection and Hyperinflammatory Phenotype in COVID-19 Coronavirus Disease 2019 Pneumonia Patients
Sponsor: Brno University Hospital
Organization: Brno University Hospital

Study Overview

Official Title: Superinfection and Hyperinflammatory Phenotype in COVID-19 Coronavirus Disease 2019 Pneumonia Patients SUPER-HI - Prospective Observational Study
Status: UNKNOWN
Status Verified Date: 2022-06
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SUPER-HI
Brief Summary: Patients suffering from COVID-19 Coronavirus Disease 2019 pneumonia are prone to bacterial and mycotic superinfection According to existing evidence the prevalence of superinfection is about 8 to 14 95 CI 5-26 However the percentage of patients treated for superinfection is as high as 80 There can be multiple reasons for this difference
Detailed Description: The inflammatory markers such as C-reactive protein CRP procalcitonin PCT presepsin PSP interleukin-6 IL-6 frequently used as diagnostic tools in COVID-19 Coronavirus Disease 2019 are usually increased in these patients This increase is a result of activation of systemic inflammatory cascade part of COVID-19 pathophysiologic pathway This can escalate to state known as COVID-19 associated hyperinflamation COV-HI In addition current diagnostic tools for diagnosing HAPVAP hospital-acquired pneumonia and ventilator-associated pneumonia are often limited in patients with COVID-19 pneumonia The current method of choice for superinfection diagnosing is BAL Bronchoalveolar Lavage The COV-HI phenotype COV-HI CRP 150 mgL or doubling within 24 h from greater than 50 mgL or ferritin concentration 1500 ugL is associated with significantly worse course of illness and higher mortality rates These inflammatory markers may be used preferentially as prognostication tools not bacterial superinfection markers The intention of this project is to investigate the role of currently used inflammatory biomarkers Or eventually to discover new parameters associated with superinfection proven by BAL

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None