NCT04896866

Efficacy and Safety of Antimicrobial Stewardship Intervention in Hospitalized COVID-19 Patients (COVASP)

Efficacy and Safety of Antimicrobial Stewardship Intervention in Hospitalized COVID-19 Patients: A Pragmatic Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 833 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 149.9 million laboratory confirmed cases and over 3.1 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 1:1 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.

Conditions

• Covid19
• COVID-19 Pneumonia
• COVID-19 Lower Respiratory Infection
• COVID-19 Acute Respiratory Distress Syndrome
• SARS-CoV2 Infection
• SARS-CoV-2 Acute Respiratory Disease

Interventions

Type	Name	Description
BEHAVIORAL	Antimicrobial stewardship prospective audit and feedback	Audits are performed on weekdays, less statutory holidays, by members of the antimicrobial stewardship team consisting of infectious disease or antimicrobial stewardship physicians or pharmacists. Verbal and written feedback will be provided in real-time. Initial prospective audit and feedback (PAF) will occur on the day of enrolment. Follow-up PAF will occur weekly (+/-3 days to account for weekends or statuary holidays) and ad-hoc if a new antibacterial is prescribed, until the primary end-point. Appropriateness will be assessed based on local clinical practice guidelines. Only antibacterials will be audited. Prescriptions will be excluded from PAF if they are single doses or discontinued prior to PAF. Prescriptions will be also be excluded from PAF and the final analysis if being used for surgical or medical prophylaxis.

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-10-15
• Completion: 2021-11-30
• First posted: 2021-05-21
• Last updated: 2024-09-19

Locations

3 sites across 1 country: Canada