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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Viral; Pneumonia; Pneumonia, Bacterial
• Intervention / Treatment: Behavioral: Electronic alert; Behavioral: Structured communication of test results

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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center - Midtown Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electronic alert plus structured communication of test results; 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; 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.; Behavioral: Structured communication of test results; 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.
Active Comparator: Electronic alert without structured communication of test results; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Duration of hospitalization from admission to discharge	Up to 90 days after randomization
In-hospital mortality	Death or discharge to hospice during initial hospitalization for any cause	Up to 90 days after randomization
Readmissions within 30-days of randomization	Readmissions for any cause within 30-days of randomization	Within 30 days after randomization
C. difficile infections in the 30-days post-randomization	Positive test for C. difficile associated with initiation of antibiotics targeting C. difficile.	Within 30 days after randomization
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.	Within 14 days of randomization
Ventilator-free days in the 30-days post-randomization	Days without a requirement for mechanical ventilation in the 30 days after randomization.	30 days after randomization.
Hospital-free days in the 30-days post-randomization	Days without hospitalization in the 30 days after randomization.	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.	3 days after randomization.

Collaborators and Investigators

• Sponsor: Jonathan Baghdadi
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Daniel J. Morgan, MD, MS, University of Maryland, Baltimore

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): January 10, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: antimicrobial stewardship; diagnostic stewardship
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Pneumonia, Bacterial; Pneumonia, Viral
• Other Study ID Numbers: HP-00103497; HP-00096125 (Other Identifier: University of Maryland Baltimore IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No