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

September 11, 2024 updated by: University of Alberta

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

833

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
      • Edmonton, Alberta, Canada, T6L 5X8
        • Grey Nuns Community Hospital
      • Edmonton, Alberta, Canada, T5R 4H5
        • Misericordia Community Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antimicrobial stewardship
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.
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.
No Intervention: No antimicrobial stewardship
No antimicrobial stewardship prospective audit and feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ordinal scale
Time Frame: 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.
Day 15 of hospital admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: through study completion, an average of 5 days
Duration of hospitalization in days
through study completion, an average of 5 days
In-hospital mortality
Time Frame: through study completion, an average of 5 days
Death occurring during hospital admission
through study completion, an average of 5 days
30-day mortality
Time Frame: 30 days
Mortality in the first 30 days after diagnosis
30 days
30-day C. difficile associated mortality
Time Frame: 30 days
Death related to C. difficile-associated diarrhea in the first 30 days after diagnosis
30 days
30 day re-admission rate
Time Frame: 30 days from hospital discharge
Re-admission to hospital after initial discharge in the first 30 days after diagnosis
30 days from hospital discharge
Days of therapy normalized for patient-days
Time Frame: capped at 30 days of hospitalization
Days of antibiotic therapy normalized for patients-day
capped at 30 days of hospitalization
Length of total antimicrobial therapy normalized for patient-days
Time Frame: capped at 30 days of hospitalization
Length of antibiotics normalized for patient-days
capped at 30 days of hospitalization
Number of antimicrobial stewardship audits
Time Frame: through study completion, an average of 5 days
Number of audits by ASP
through study completion, an average of 5 days
Number of antimicrobial stewardship recommendations
Time Frame: through study completion, an average of 5 days
Number of recommendations by ASP
through study completion, an average of 5 days
Antimicrobial stewardship acceptance rates
Time Frame: through study completion, an average of 5 days
Acceptance rate of ASP recommendations
through study completion, an average of 5 days
Multi-drug resistant bacteria infection rates
Time Frame: 30 days
Development of multi-drug resistant bacterial infection in the first 30 days after diagnosis
30 days
Clostridioides difficile infection rate
Time Frame: 30 days
C. difficile-associated diarrhea in the first 30 days after diagnosis
30 days
Percentage of participants with neutropenia
Time Frame: 30 days
Occurrence of neutropenia in the first 30 days
30 days
Acute kidney injury
Time Frame: 30 days
diagnosed and staged as according to KDIGO
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

October 15, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00105598

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol will be published in an open journal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Antimicrobial stewardship prospective audit and feedback

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe