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Completed

NCT Number: NCT04896866

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

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.

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Key information

Conditions

Covid19 COVID-19 COVID-19 Acute Respiratory Distress Syndrome COVID-19 Lower Respiratory Infection COVID-19 Pneumonia Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Acute Respiratory Disease SARS-CoV2 Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grey Nuns Community Hospital, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Ordinal scale

    Time frame: Day 15 of hospital admission

    A 7 point ordinal scale of clinical outcomes:

    • point - Not hospitalized, able to resume normal daily activities
    • points - Not hospitalized, unable to resume normal daily activities
    • points - Hospitalized, not on supplemental oxygen
    • points - Hospitalized, on supplemental oxygen
    • points - Hospitalized, on high flow oxygen therapy or non-invasive mechanical ventilation
    • points - Hospitalized, on ECMO or invasive mechanical ventilation
    • points - Death

    Higher scores means a worse outcome.

Secondary outcomes

  1. Length of hospital stay

    Time frame: through study completion, an average of 5 days

    Duration of hospitalization in days

  2. In-hospital mortality

    Time frame: through study completion, an average of 5 days

    Death occurring during hospital admission

  3. 30-day mortality

    Time frame: 30 days

    Mortality in the first 30 days after diagnosis

  4. 30-day C. difficile associated mortality

    Time frame: 30 days

    Death related to C. difficile-associated diarrhea in the first 30 days after diagnosis

  5. 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

  6. Days of therapy normalized for patient-days

    Time frame: capped at 30 days of hospitalization

    Days of antibiotic therapy normalized for patients-day

  7. Length of total antimicrobial therapy normalized for patient-days

    Time frame: capped at 30 days of hospitalization

    Length of antibiotics normalized for patient-days

  8. Number of antimicrobial stewardship audits

    Time frame: through study completion, an average of 5 days

    Number of audits by ASP

  9. Number of antimicrobial stewardship recommendations

    Time frame: through study completion, an average of 5 days

    Number of recommendations by ASP

  10. Antimicrobial stewardship acceptance rates

    Time frame: through study completion, an average of 5 days

    Acceptance rate of ASP recommendations

  11. Multi-drug resistant bacteria infection rates

    Time frame: 30 days

    Development of multi-drug resistant bacterial infection in the first 30 days after diagnosis

  12. Clostridioides difficile infection rate

    Time frame: 30 days

    C. difficile-associated diarrhea in the first 30 days after diagnosis

  13. Percentage of participants with neutropenia

    Time frame: 30 days

    Occurrence of neutropenia in the first 30 days

  14. Acute kidney injury

    Time frame: 30 days

    diagnosed and staged as according to KDIGO

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Acronym: COVASP

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 21, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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