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NCT Number: NCT05976581

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Medical Center, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Electronic Alert

Behavioral

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.

Structured communication of test results

Behavioral

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 outcomes

  1. Hospital antibiotic days of therapy

    Time frame: Up 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 outcomes

  1. Hospital length of stay

    Time frame: Up to 90 days after randomization

    Duration of hospitalization from admission to discharge

  2. In-hospital mortality

    Time frame: Up to 90 days after randomization

    Death or discharge to hospice during initial hospitalization for any cause

  3. Readmissions within 30-days of randomization

    Time frame: Within 30 days after randomization

    Readmissions for any cause within 30-days of randomization

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

    Time frame: Within 30 days after randomization

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

  5. Acute kidney injury

    Time frame: Within 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.

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

    Time frame: 30 days after randomization.

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

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

    Time frame: 30 days after randomization.

    Days without hospitalization in the 30 days after randomization.

  8. Antibiotic de-escalations within 72 hours after initiation

    Time frame: 3 days after randomization.

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

Sponsors and collaborators

Lead sponsor

Jonathan Baghdadi

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Acronym: UP-CAPTAIn

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2023
Registry last updated
Apr 14, 2026

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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