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

Pneumonia Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05976581
• Other study ID #: HP-00103497
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: February 2024
• Source: University of Maryland, Baltimore
• Contact: Jonathan D Baghdadi, MD, PhD
• Phone: 410-706-0134
• Email: jbaghdadi[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Bacterial
• Pneumonia, Viral

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Maryland Medical Center - Midtown Campus	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Jonathan Baghdadi	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospital length of stay	Duration of hospitalization from admission to discharge	Up to 90 days after randomization
Secondary	In-hospital mortality	Death or discharge to hospice during initial hospitalization for any cause	Up to 90 days after randomization
Secondary	Readmissions within 30-days of randomization	Readmissions for any cause within 30-days of randomization	Within 30 days after randomization
Secondary	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
Secondary	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
Secondary	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.
Secondary	Hospital-free days in the 30-days post-randomization	Days without hospitalization in the 30 days after randomization.	30 days after randomization.
Secondary	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.