Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896866
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2021-05-17
Brief Title:
Efficacy and Safety of Antimicrobial Stewardship Intervention in Hospitalized COVID-19 Patients COVASP
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Efficacy and Safety of Antimicrobial Stewardship Intervention in Hospitalized COVID-19 Patients A Pragmatic Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
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:
COVASP
Brief Summary:
COVID-19 is respiratory disease caused by the severe acute respiratory coronavirus 2 SARS-CoV-2 a novel coronavirus which has spread rapidly across the world with over 1499 million laboratory confirmed cases and over 31 million reported deaths since December 2019 Approximately 4-8 of hospitalized patients with COVID-19 have co-infection with bacterial pathogens however there is widespread and often broad-spectrum antibiotic use in these patients
This is a prospective multi-center non-inferiority pragmatic clinical trial of antimicrobial stewardship prospective audit and feedback versus no antimicrobial stewardship intervention on physicians attending to patients with proven SARS-CoV-2 infection confirmed by nucleic acid testing in the preceding 2 weeks of hospitalization for acute COVID-19 pneumonia Prospective audit and feedback is the real time review of antibacterial prescriptions and immediate feedback to prescribers to optimize antimicrobial prescriptions Hospital beds will be stratified by COVID unit and critical care unit beds and will be computer randomized in a 11 fashion into 2 arms antimicrobial stewardship intervention versus no antimicrobial stewardship intervention prior to study commencement at the participating site Patients hospitalized to study-eligible beds will be followed for primary and secondary outcomes
The objective of this study is to determine the effect of an antimicrobial stewardship intervention prospective audit and feedback on clinical outcomes in patients hospitalized with acute COVID-19
This is a prospective multi-center non-inferiority pragmatic clinical trial of antimicrobial stewardship prospective audit and feedback versus no antimicrobial stewardship intervention on physicians attending to patients with proven SARS-CoV-2 infection confirmed by nucleic acid testing in the preceding 2 weeks of hospitalization for acute COVID-19 pneumonia Prospective audit and feedback is the real time review of antibacterial prescriptions and immediate feedback to prescribers to optimize antimicrobial prescriptions Hospital beds will be stratified by COVID unit and critical care unit beds and will be computer randomized in a 11 fashion into 2 arms antimicrobial stewardship intervention versus no antimicrobial stewardship intervention prior to study commencement at the participating site Patients hospitalized to study-eligible beds will be followed for primary and secondary outcomes
The objective of this study is to determine the effect of an antimicrobial stewardship intervention prospective audit and feedback on clinical outcomes in patients hospitalized with acute COVID-19
Detailed Description:
None
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