Reducing Antimicrobial Overuse Through Targeted Therapy for Patients With Community-Acquired Pneumonia

Last updated: July 9, 2024
Sponsor: The Cleveland Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pneumonia

Pneumonia (Pediatric)

Treatment

Pharmacist-led de-escalation

Rapid Diagnostic Testing

Clinical Study ID

NCT05568654
21-863
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to reduce the exposure of broad-spectrum antimicrobials by optimizing the rapid detection of CAP pathogens and improving rates of de-escalation following negative cultures. To accomplish this, we will perform a 3-year, pragmatic, multicenter 2 X 2 factorial cluster randomized controlled trial with four arms: a) rapid diagnostic testing b) pharmacist-led de-escalation c) rapid diagnostic testing + pharmacist-led de-escalation and d) usual care

Eligibility Criteria

Inclusion

Inclusion Criteria for patient's records:

  1. Men or women greater than or equal to 18 years of age

  2. Admitted to a participating (i.e. enrolled and randomized) hospital

  3. Admitting diagnosis of pneumonia

Exclusion

Exclusion Criteria:

  1. Admission to intensive care unit within 24 hours of hospital admission

  2. Comfort care measures only

  3. Cystic fibrosis

  4. Discharged from an acute care hospital in the past week

  5. Patients not eligible for empiric therapy due to a known pathogen (any positiveblood or respiratory cultures in the 72 hours prior to admission)

Study Design

Total Participants: 12500
Treatment Group(s): 2
Primary Treatment: Pharmacist-led de-escalation
Phase:
Study Start date:
November 01, 2022
Estimated Completion Date:
June 30, 2026

Study Description

Community-acquired pneumonia (CAP) is a leading cause of hospitalization and inpatient antimicrobial use in the United States. However, diagnostic uncertainty at the time of initial treatment and following negative cultures is associated with prolonged exposure to broad-spectrum antimicrobials. We propose a large multicenter cluster randomized controlled trial to test two approaches to reducing the use of broad-spectrum antibiotics in adult patients with CAP a) routine use of rapid diagnostic testing at the time of admission and b) pharmacist -led de-escalation after 48 hours for clinically stable patients with negative cultures.

When a patient is admitted with a diagnosis of pneumonia, it will trigger the admission order set and if the physician is in a hospital randomized to the rapid diagnostic testing arm, a CDSS-based alert will be generated in real time, and the form will append orders for viral and UAT testing. For physicians at a hospital randomized to the control condition, ordering will proceed as usual (standard-of-care). A second CDSS algorithm will identify study patients who have negative culture results (blood and/or sputum) for greater than 48 hours and generate a list for the antimicrobial stewardship pharmacist, who will be a member of the study team. The alerts will be audited by the clinical pharmacist daily on weekdays at a centralized location. In clinically stable patients from hospitals randomized to the de-escalation arm, the pharmacist will communicate their recommendations for de-escalation to the clinical providers via a phone call, Epic chat, or page. The primary outcome will be the duration of exposure to broad-spectrum antimicrobial therapy defined by the number of days of antibiotic therapy from initiation to discontinuation. Secondary outcomes will include detection of influenza/RSV, de-escalation and re-escalation to broad-spectrum antibiotics after de-escalation, total antibiotic duration, in-hospital mortality, ICU transfer after admission, healthcare-associated CDI and acute kidney injury after 48 hours.

Connect with a study center

  • Indian River Hospital

    Vero Beach, Florida 32960
    United States

    Active - Recruiting

  • Weston Hospital/Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Active - Recruiting

  • Akron General Hospital

    Akron, Ohio 44307
    United States

    Active - Recruiting

  • Avon Hospital

    Avon, Ohio 44011
    United States

    Active - Recruiting

  • Cleveland Clinic Main Campus

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Lutheran Hospital

    Cleveland, Ohio 44113
    United States

    Active - Recruiting

  • Euclid Hospital

    Euclid, Ohio 44119
    United States

    Active - Recruiting

  • Fairview Hospital

    Fairview Park, Ohio 44111
    United States

    Active - Recruiting

  • Marymount Hospital

    Garfield Heights, Ohio 44125
    United States

    Active - Recruiting

  • Hillcrest Hospital

    Mayfield Heights, Ohio 44124
    United States

    Active - Recruiting

  • Medina Hospital

    Medina, Ohio 44256
    United States

    Active - Recruiting

  • South Pointe Hospital

    Warrensville Heights, Ohio 44122
    United States

    Active - Recruiting

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