Clinical trial NCT04896866: Efficacy and Safety of Antimicrobial Stewardship Intervention in Hospitalized COVID-19 Patients (COVASP)
Official title: Efficacy and Safety of Antimicrobial Stewardship Intervention in Hospitalized COVID-19 Patients: A Pragmatic Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Keywords: antimicrobial stewardship
antibiotic stewardship
prospective audit and feedback
quality improvement
antibiotics
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 833
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hospital beds are randomized prior to enrolment to intervention versus observation. Intervention consists of antimicrobial stewardship prospective audit and feedback.
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ordinal scale
timeFrame: Day 15 of hospital admission
Secondary outcomes:
measure: Length of hospital stay
timeFrame: through study completion, an average of 5 days
measure: In-hospital mortality
timeFrame: through study completion, an average of 5 days
measure: 30-day mortality
timeFrame: 30 days
measure: 30-day C. difficile associated mortality
timeFrame: 30 days
measure: 30 day re-admission rate
timeFrame: 30 days from hospital discharge
measure: Days of therapy normalized for patient-days
timeFrame: capped at 30 days of hospitalization
measure: Length of total antimicrobial therapy normalized for patient-days
timeFrame: capped at 30 days of hospitalization
measure: Number of antimicrobial stewardship audits
timeFrame: through study completion, an average of 5 days
measure: Number of antimicrobial stewardship recommendations
timeFrame: through study completion, an average of 5 days
measure: Antimicrobial stewardship acceptance rates
timeFrame: through study completion, an average of 5 days
measure: Multi-drug resistant bacteria infection rates
timeFrame: 30 days
measure: Clostridioides difficile infection rate
timeFrame: 30 days
measure: Percentage of participants with neutropenia
timeFrame: 30 days
measure: Acute kidney injury
timeFrame: 30 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Misericordia Community Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
Study officials:
References:
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