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Completed

NCT Number: NCT05172791

Decreasing Unnecessary Antibiotics Prescribed for Possible Pneumonia Despite Normal Respiratory Rate and Oxygenation

The purpose of this study is to decrease unnecessary antibiotics prescribed to hospitalized patients for possible pneumonia by flagging patients with respiratory rates and oxygenation levels within reference ranges given prior data suggesting that discontinuing antibiotics in this population is safe. Patients will be randomized to 3 arms: 1) usual care, 2) electronic alert, or 3) pharmacist outreach.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

About this study

Prior data suggest antibiotic starts for patients with normal vital signs are common and there does not appear to be harm associated with stopping antibiotics after only 1 or 2 days in patients with normal oxygen saturations. We therefore propose a pilot patient-level three-way randomized trial to determine the best way to operationalize professional society recommendations for post-prescription antibiotic reviews amongst patients started on antibiotics with a stated indication of pneumonia despite normal respiratory rates and oxygenation levels. If the patient's median respiratory rate and oxygen saturation is normal after 1-2 days of antibiotics they will be randomized to usual care versus a EHR-based best practice alert versus pharmacist outreach. The EHR-based best practice alert will highlight the patient's normal respiratory rate and oxygenation and encourage stopping antibiotics if there isn't another indication for antibiotics. Pharmacist outreach will involve contacting the responding clinician or attending physician to determine the working diagnosis, review the patient's vital signs, and to ask the team to consider stopping antibiotics if there are no clear indications for antibiotics. In all cases, the final decision on whether to stop or continue antibiotics will be up to the primary team. We will assess the impact of these post-prescription review strategies to decrease unnecessary antibiotic utilization on antibiotic utilization (antibiotic days and antibiotic-free days) compared to usual care. Safety outcomes will include time to discharge, readmissions, hospital-free days, and mortality. We will also assess for change in the primary outcome over time.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients admitted to Brigham and Women's and BWH Faulkner Hospitals and prescribed antibiotics with a stated indication of pneumonia who have a median respiratory rate of ≤20 and oxygen saturation of ≥95% without supplemental oxygen sustained for at least 24 hours.

Exclusion criteria

  • Patients under 18 years old, patients on transplant and oncology services, patients who are pregnant, patients in an intensive care unit, patients with cystic fibrosis or bronchiectasis, patients on immunosuppressive medications, and patients with positive blood cultures (other than common skin contaminants)

Treatment and study plan

Antibiotic stewardship messaging

Behavioral

Counseling regarding antibiotics for patients prescribed antibiotics for possible pneumonia despite respiratory rates and oxygenation levels within normal ranges

Primary outcomes

  1. Duration of antibiotics prescribed for pneumonia

    Time frame: Number of days of antibiotics given during hospitalization plus number of days of antibiotics for pneumonia on discharge prescriptions, up to 30 days

    Duration of antibiotics prescribed for pneumonia

Secondary outcomes

  1. Antibiotic-free days in the 30-days post-randomization

    Time frame: 30-days post-randomization

    Antibiotic-free days in the 30-days post-randomization

  2. Days from randomization to discharge

    Time frame: Duration of hospitalization, up to 90 days

    Days from randomization to discharge

  3. Hospital length of stay

    Time frame: Duration of hospitalization, up to 90 days

    Hospital length of stay

  4. In-hospital mortality

    Time frame: During initial hospitalization with pneumonia, up to 90 days

    In-hospital mortality

  5. Readmissions within 30-days of randomization

    Time frame: 30-days post-randomization

    Readmissions within 30-days of randomization

  6. Hospital-free days in the 30-days post-randomization

    Time frame: 30-days post-randomization

    Hospital-free days in the 30-days post-randomization

  7. C. difficile infections in the 30-days post-randomization

    Time frame: 30-days post-randomization

    C. difficile infections in the 30-days post-randomization

  8. Acute kidney injury (maximum creatinine in the 14-days post-randomization)

    Time frame: 14 days post-randomization

    Acute kidney injury (maximum creatinine in the 14-days post-randomization)

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 29, 2021
Registry last updated
Nov 21, 2025

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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