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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
833
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.
Misericordia Community Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, Canada
Ordinal scale
A 7 point ordinal scale of clinical outcomes: 1. point - Not hospitalized, able to resume normal daily activities 2. points - Not hospitalized, unable to resume normal daily activities 3. points - Hospitalized, not on supplemental oxygen 4. points - Hospitalized, on supplemental oxygen 5. points - Hospitalized, on high flow oxygen therapy or non-invasive mechanical ventilation 6. points - Hospitalized, on ECMO or invasive mechanical ventilation 7. points - Death Higher scores means a worse outcome.
Time frame: Day 15 of hospital admission
Length of hospital stay
Duration of hospitalization in days
Time frame: through study completion, an average of 5 days
In-hospital mortality
Death occurring during hospital admission
Time frame: through study completion, an average of 5 days
30-day mortality
Mortality in the first 30 days after diagnosis
Time frame: 30 days
30-day C. difficile associated mortality
Death related to C. difficile-associated diarrhea in the first 30 days after diagnosis
Time frame: 30 days
30 day re-admission rate
Re-admission to hospital after initial discharge in the first 30 days after diagnosis
Time frame: 30 days from hospital discharge
Days of therapy normalized for patient-days
Days of antibiotic therapy normalized for patients-day
Time frame: capped at 30 days of hospitalization
Length of total antimicrobial therapy normalized for patient-days
Length of antibiotics normalized for patient-days
Time frame: capped at 30 days of hospitalization
Number of antimicrobial stewardship audits
Number of audits by ASP
Time frame: through study completion, an average of 5 days
Number of antimicrobial stewardship recommendations
Number of recommendations by ASP
Time frame: through study completion, an average of 5 days
Antimicrobial stewardship acceptance rates
Acceptance rate of ASP recommendations
Time frame: through study completion, an average of 5 days
Multi-drug resistant bacteria infection rates
Development of multi-drug resistant bacterial infection in the first 30 days after diagnosis
Time frame: 30 days
Clostridioides difficile infection rate
C. difficile-associated diarrhea in the first 30 days after diagnosis
Time frame: 30 days
Percentage of participants with neutropenia
Occurrence of neutropenia in the first 30 days
Time frame: 30 days
Acute kidney injury
diagnosed and staged as according to KDIGO
Time frame: 30 days
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