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Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients (UP-CAPTAIn)

Primary Purpose

Pneumonia, Pneumonia, Viral, Pneumonia, Bacterial

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electronic alert
Structured communication of test results
Sponsored by
Jonathan Baghdadi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pneumonia focused on measuring diagnostic stewardship, antimicrobial stewardship

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Electronic alert plus structured communication of test results

    Electronic alert without structured communication of test results

    Arm Description

    An 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.

    An 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.

    Outcomes

    Primary Outcome Measures

    Hospital antibiotic days of therapy
    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

    Hospital length of stay
    Duration of hospitalization from admission to discharge
    In-hospital mortality
    Death or discharge to hospice during initial hospitalization for any cause
    Readmissions within 30-days of randomization
    Readmissions for any cause within 30-days of randomization
    C. difficile infections in the 30-days post-randomization
    Positive test for C. difficile associated with initiation of antibiotics targeting C. difficile.
    Acute kidney injury
    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-randomization
    Days without a requirement for mechanical ventilation in the 30 days after randomization.
    Hospital-free days in the 30-days post-randomization
    Days without hospitalization in the 30 days after randomization.
    Antibiotic de-escalations within 72 hours after initiation
    Including narrowing, discontinuing, or converting the route of administration from intravenous to oral.

    Full Information

    First Posted
    July 11, 2023
    Last Updated
    September 26, 2023
    Sponsor
    Jonathan Baghdadi
    Collaborators
    Centers for Disease Control and Prevention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05976581
    Brief Title
    Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients
    Acronym
    UP-CAPTAIn
    Official Title
    Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 15, 2024 (Anticipated)
    Study Completion Date
    December 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jonathan Baghdadi
    Collaborators
    Centers for Disease Control and Prevention

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia, Pneumonia, Viral, Pneumonia, Bacterial
    Keywords
    diagnostic stewardship, antimicrobial stewardship

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Electronic alert plus structured communication of test results
    Arm Type
    Experimental
    Arm Description
    An 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.
    Arm Title
    Electronic alert without structured communication of test results
    Arm Type
    Active Comparator
    Arm Description
    An 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Electronic alert
    Intervention Description
    An alert will appear in the electronic health record that provides options for diagnostic testing based on low, medium, or high probability of bacterial pneumonia.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Structured communication of test results
    Intervention Description
    A clinical research team member will send an electronic message to the primary care team on behalf of the antimicrobial stewardship program with structured guidance to stop or de-escalate antibiotics and document these recommendations in the patient's chart.
    Primary Outcome Measure Information:
    Title
    Hospital antibiotic days of therapy
    Description
    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.
    Time Frame
    Up to 90 days after randomization
    Secondary Outcome Measure Information:
    Title
    Hospital length of stay
    Description
    Duration of hospitalization from admission to discharge
    Time Frame
    Up to 90 days after randomization
    Title
    In-hospital mortality
    Description
    Death or discharge to hospice during initial hospitalization for any cause
    Time Frame
    Up to 90 days after randomization
    Title
    Readmissions within 30-days of randomization
    Description
    Readmissions for any cause within 30-days of randomization
    Time Frame
    Within 30 days after randomization
    Title
    C. difficile infections in the 30-days post-randomization
    Description
    Positive test for C. difficile associated with initiation of antibiotics targeting C. difficile.
    Time Frame
    Within 30 days after randomization
    Title
    Acute kidney injury
    Description
    Defined by an elevation in creatinine of > 0.5mg/dl or 2x baseline in a patient without previous end-stage renal disease.
    Time Frame
    Within 14 days of randomization
    Title
    Ventilator-free days in the 30-days post-randomization
    Description
    Days without a requirement for mechanical ventilation in the 30 days after randomization.
    Time Frame
    30 days after randomization.
    Title
    Hospital-free days in the 30-days post-randomization
    Description
    Days without hospitalization in the 30 days after randomization.
    Time Frame
    30 days after randomization.
    Title
    Antibiotic de-escalations within 72 hours after initiation
    Description
    Including narrowing, discontinuing, or converting the route of administration from intravenous to oral.
    Time Frame
    3 days after randomization.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jonathan D Baghdadi, MD, PhD
    Phone
    410-706-0134
    Email
    jbaghdadi@som.umaryland.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel J. Morgan, MD, MS
    Organizational Affiliation
    University of Maryland, Baltimore
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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