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

NCT04896866 | Completed

• 1 other identifier: Pro00105598
• Study Type: interventional
• Target: 833
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 15 of hospital admission

Secondary Outcomes (14)

• Length of hospital stay

  through study completion, an average of 5 days

• In-hospital mortality

  through study completion, an average of 5 days

• 30-day mortality

  30 days

• 30-day C. difficile associated mortality

  30 days

• 30 day re-admission rate

  30 days from hospital discharge

Study Arms (2)

Antimicrobial stewardship

EXPERIMENTAL

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

No antimicrobial stewardship

NO INTERVENTION

No antimicrobial stewardship prospective audit and feedback.

Interventions

Antimicrobial stewardship prospective audit and feedback BEHAVIORAL

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.

Antimicrobial stewardship

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (3)

Misericordia Community Hospital

Edmonton, Alberta, T5R 4H5, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, T6L 5X8, Canada

Location

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MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hospital beds are randomized prior to enrolment to intervention versus observation. Intervention consists of antimicrobial stewardship prospective audit and feedback.

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 21, 2021
• Study Start: March 1, 2021
• Primary Completion: October 15, 2021
• Study Completion: November 30, 2021
• Last Updated: September 19, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CA (3)