Efficacy and Safety of Antimicrobial Stewardship Intervention in Hospitalized COVID-19 Patients (COVASP)
- Conditions
- Covid19COVID-19 PneumoniaSARS-CoV2 InfectionCOVID-19 Lower Respiratory InfectionCOVID-19 Acute Respiratory Distress SyndromeSARS-CoV-2 Acute Respiratory Disease
- Interventions
- Behavioral: Antimicrobial stewardship prospective audit and feedback
- Registration Number
- NCT04896866
- Lead Sponsor
- University of Alberta
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 833
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antimicrobial stewardship Antimicrobial stewardship prospective audit and feedback Antimicrobial stewardship prospective audit and feedback on physicians attending to patients admitted with community-acquired COVID-19 pneumonia to beds randomized to antimicrobial stewardship intervention.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 30-day mortality 30 days Mortality in the first 30 days after diagnosis
Antimicrobial stewardship acceptance rates through study completion, an average of 5 days Acceptance rate of ASP recommendations
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
In-hospital mortality through study completion, an average of 5 days Death occurring during hospital admission
30 day re-admission rate 30 days from hospital discharge Re-admission to hospital after initial discharge 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
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
Number of antimicrobial stewardship recommendations through study completion, an average of 5 days Number of recommendations by ASP
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
Trial Locations
- Locations (3)
Grey Nuns Community Hospital
🇨🇦Edmonton, Alberta, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Misericordia Community Hospital
🇨🇦Edmonton, Alberta, Canada