Clinical trial NCT05976581: Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients
Official title: Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pneumonia
Pneumonia, Viral
Pneumonia, Bacterial
Keywords: diagnostic stewardship
antimicrobial stewardship
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2023-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Hospital antibiotic days of therapy
timeFrame: Up to 90 days after randomization
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Up to 90 days after randomization
measure: In-hospital mortality
timeFrame: Up to 90 days after randomization
measure: Readmissions within 30-days of randomization
timeFrame: Within 30 days after randomization
measure: C. difficile infections in the 30-days post-randomization
timeFrame: Within 30 days after randomization
measure: Acute kidney injury
timeFrame: Within 14 days of randomization
measure: Ventilator-free days in the 30-days post-randomization
timeFrame: 30 days after randomization.
measure: Hospital-free days in the 30-days post-randomization
timeFrame: 30 days after randomization.
measure: Antibiotic de-escalations within 72 hours after initiation
timeFrame: 3 days after randomization.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center - Midtown Campus
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Daniel J. Morgan, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: