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Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients

Not Applicable
Active, not recruiting
Conditions
Pneumonia
Pneumonia, Viral
Pneumonia, Bacterial
Interventions
Behavioral: Electronic alert
Behavioral: Structured communication of test results
Registration Number
NCT05976581
Lead Sponsor
Jonathan Baghdadi
Brief Summary

The goal of this prospective randomized study is to improve antibiotic use among hospitalized patients with suspected pneumonia. An alert was built into the electronic health record to guide use of diagnostic testing based on probability of bacterial pneumonia. Patients with test results suggesting viral infection will be randomized to either: (1) receive a structured communication from the antimicrobial stewardship team to de-escalate antibiotics or (2) usual care.

Detailed Description

Low-risk patients with viral pneumonia do not benefit from and may be harmed by antibiotic therapy. In this study, an alert will appear in the electronic health record of patients undergoing molecular diagnostic testing for respiratory symptoms that provides options for diagnostic testing based on pre-test probability of bacterial infection. Patients with test results suggesting possible viral infection will be randomized to either usual care or to receive test results along with structured guidance from antimicrobial stewardship to consider discontinuing or de-escalating antibiotics. This guidance, which will include an explicit calculation of the post-test probability of bacterial infection based on considering risk factors, vital signs, symptoms, and available imaging, will be communicated to the primary care team via direct electronic message and a summary note in the patient's chart. The final decision on whether to continue antibiotic therapy will be up to the primary team. The primary outcome of interest will be in-hospital antibiotic use. Safety outcomes will include length of stay, readmissions, hospital-free days, and mortality.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Adult patients admitted to the University of Maryland Medical Center or University of Maryland Medical Center-Midtown Campus who are prescribed antibiotics for suspected community-acquired respiratory infection.
  • Protocol-based diagnostic testing supports possible viral infection, either by positive molecular test or low procalcitonin value.
Exclusion Criteria
  • Hospitalization for >72 hours prior to protocol-based diagnostic testing.
  • Previous molecular testing for viral infection during the same hospital encounter.
  • Severely immunosuppressed, defined as having hematologic malignancy, solid organ tumor on chemotherapy, or solid organ transplant on immunosuppression

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Electronic alert plus structured communication of test resultsStructured communication of test resultsAn electronic health record alert will guide diagnostic testing for pneumonia. For patients with low or moderate probability of bacterial pneumonia, test results will be communicated to the primary team with guidance to consider discontinuing or de-escalating antibiotics.
Electronic alert plus structured communication of test resultsElectronic alertAn electronic health record alert will guide diagnostic testing for pneumonia. For patients with low or moderate probability of bacterial pneumonia, test results will be communicated to the primary team with guidance to consider discontinuing or de-escalating antibiotics.
Electronic alert without structured communication of test resultsElectronic alertAn electronic health record alert will guide diagnostic testing for pneumonia. The primary care team will access and interpret test results and decide upon composition and duration of antimicrobial without external guidance.
Primary Outcome Measures
NameTimeMethod
Hospital antibiotic days of therapyUp to 90 days after randomization

The aggregate sum of days for which any amount of a specific antimicrobial agent was administered during the hospital encounter, from arrival in the emergency department or on the hospital ward until discharge.

Secondary Outcome Measures
NameTimeMethod
Antibiotic de-escalations within 72 hours after initiation3 days after randomization.

Including narrowing, discontinuing, or converting the route of administration from intravenous to oral.

Acute kidney injuryWithin 14 days of randomization

Defined by an elevation in creatinine of \> 0.5mg/dl or 2x baseline in a patient without previous end-stage renal disease.

Ventilator-free days in the 30-days post-randomization30 days after randomization.

Days without a requirement for mechanical ventilation in the 30 days after randomization.

Hospital-free days in the 30-days post-randomization30 days after randomization.

Days without hospitalization in the 30 days after randomization.

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

Positive test for C. difficile associated with initiation of antibiotics targeting C. difficile.

In-hospital mortalityUp to 90 days after randomization

Death or discharge to hospice during initial hospitalization for any cause

Readmissions within 30-days of randomizationWithin 30 days after randomization

Readmissions for any cause within 30-days of randomization

Hospital length of stayUp to 90 days after randomization

Duration of hospitalization from admission to discharge

Trial Locations

Locations (2)

University of Maryland Medical Center - Midtown Campus

🇺🇸

Baltimore, Maryland, United States

University of Maryland Medical Center

🇺🇸

Baltimore, Maryland, United States

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