Covid19, COVID-19 Acute Respiratory Distress Syndrome, COVID-19 Lower Respiratory Infection, COVID-19 Pneumonia, SARS-CoV-2 Acute Respiratory Disease, SARS-CoV2 Infection
Conditions
Keywords
antimicrobial stewardship, antibiotic stewardship, prospective audit and feedback, quality improvement, antibiotics
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 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.
Interventions
BEHAVIORALAntimicrobial 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.
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Hospital beds are randomized prior to enrolment to intervention versus observation. Intervention consists of antimicrobial stewardship prospective audit and feedback.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years at the time of hospital admission. * Confirmed SARS-CoV-2 infection by nucleic acid testing in the preceding 14 days of hospital admission. * Admitted from the community (including continuing care facilities). * Admitted to a hospital bed designated in the study. * SpO2 ≤94% requiring supplemental oxygen or chest imaging findings compatible with COVID-19 pneumonia.
Exclusion criteria
* The patient is enrolled in another clinical trial that involves antibacterial therapy. * The patient's goals of care is anticipated to be designated total compassionate care or palliative care within 48 hours of admission. * The patient's progression to death is anticipated to be imminent and inevitable within 48 hours of admission. * The patient was attended by any member of the research team within 30 days of enrollment. * The patient is transferred from another acute care center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ordinal scale | Day 15 of hospital admission | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antimicrobial stewardship acceptance rates | through study completion, an average of 5 days | Acceptance rate of ASP recommendations |
| Multi-drug resistant bacteria infection rates | 30 days | Development of multi-drug resistant bacterial infection in the first 30 days after diagnosis |
| Clostridioides difficile infection rate | 30 days | C. difficile-associated diarrhea in the first 30 days after diagnosis |
| Percentage of participants with neutropenia | 30 days | Occurrence of neutropenia in the first 30 days |
| Acute kidney injury | 30 days | diagnosed and staged as according to KDIGO |
| Length of hospital stay | through study completion, an average of 5 days | Duration of hospitalization in days |
| Number of antimicrobial stewardship recommendations | through study completion, an average of 5 days | Number of recommendations by ASP |
| 30-day mortality | 30 days | Mortality in the first 30 days after diagnosis |
| 30-day C. difficile associated mortality | 30 days | Death related to C. difficile-associated diarrhea in the first 30 days after diagnosis |
| 30 day re-admission rate | 30 days from hospital discharge | Re-admission to hospital after initial discharge in the first 30 days after diagnosis |
| Days of therapy normalized for patient-days | capped at 30 days of hospitalization | Days of antibiotic therapy normalized for patients-day |
| Length of total antimicrobial therapy normalized for patient-days | capped at 30 days of hospitalization | Length of antibiotics normalized for patient-days |
| Number of antimicrobial stewardship audits | through study completion, an average of 5 days | Number of audits by ASP |
| In-hospital mortality | through study completion, an average of 5 days | Death occurring during hospital admission |
Countries
Canada
Outcome results
None listed