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

NCT05976581 | Completed

• 1 other identifier: HP-00103497
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 2

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.

Conditions

Pneumonia; Pneumonia, Viral; Pneumonia, Bacterial

Keywords

diagnostic stewardship; antimicrobial stewardship

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 90 days after randomization

Secondary Outcomes (8)

• Hospital length of stay

  Up to 90 days after randomization

• In-hospital mortality

  Up to 90 days after randomization

• Readmissions within 30-days of randomization

  Within 30 days after randomization

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

  Within 30 days after randomization

• Acute kidney injury

  Within 14 days of randomization

Study Arms (2)

Electronic alert plus structured communication of test results

EXPERIMENTAL

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.

Behavioral: Electronic alert; Behavioral: Structured communication of test results

Electronic alert without structured communication of test results

ACTIVE COMPARATOR

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.

Behavioral: Electronic alert

Interventions

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.

Electronic alert plus structured communication of test results; Electronic alert without structured communication of test results

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.

Electronic alert plus structured communication of test results

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonathan Baghdadi: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

University of Maryland Medical Center - Midtown Campus

Baltimore, Maryland, 21201, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Baghdadi JD, Harris AD, Pineles L, Al-Shanqeeti S, Palacio D, Charles DW, Heil E, Claeys KC, Bork JT, Sommerkamp S, Wilkerson RG, Godwin G, Sutherland ME, Johnson JK, Morgan DJ. Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients: A Pragmatic, Randomized Trial. Clin Infect Dis. 2026 Mar 13:ciag126. doi: 10.1093/cid/ciag126. Online ahead of print.

  PMID: 41823187 RESULT

MeSH Terms

Conditions

Pneumonia; Pneumonia, Viral; Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Virus Diseases; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Daniel J. Morgan, MD, MS

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study involves a randomized trial embedded within a quasi-experiment. During the 1-year study period, we anticipate that 1,500 patients will be exposed to the electronic health record modification performed as part of the quasi-experiment. Regarding the randomized trial, if 100 patients are enrolled during the 1-year study period, including 50 in intervention patients and 50 controls, we anticipate that we will have sufficient precision to estimate the difference in binary outcomes (e.g., antibiotic discontinuation within 5 days) between the two groups with a margin of error of approximately 15% based on a 95% confidence interval.

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 4, 2023
• Study Start: November 1, 2023
• Primary Completion: January 10, 2025
• Study Completion: May 31, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)