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Reducing Antimicrobial Overuse Through Targeted Therapy for Patients With Community-Acquired Pneumonia
Sponsor: The Cleveland Clinic
Summary
The purpose of this study is to reduce the exposure of broad-spectrum antimicrobials by optimizing the rapid detection of CAP pathogens and improving rates of de-escalation following negative cultures. To accomplish this, we will perform a 3-year, pragmatic, multicenter 2 X 2 factorial cluster randomized controlled trial with four arms: a) rapid diagnostic testing b) pharmacist-led de-escalation c) rapid diagnostic testing + pharmacist-led de-escalation and d) usual care
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12500
Start Date
2022-11-01
Completion Date
2026-06-30
Last Updated
2026-03-05
Healthy Volunteers
No
Interventions
Rapid Diagnostic Testing
Eligible patients in hospitals randomized to this arm will undergo testing for viral pathogens (from November-April) and pneumococcal UAT and procalcitonin testing. A CDSS-based alert will be generated in real time. If the patient is not being admitted to the intensive care unit, the form will append orders for viral pathogen, UAT and procalcitonin testing.
Pharmacist-led de-escalation
A CDSS algorithm will identify CAP patients who meet study criteria and have negative culture results for greater than 48 hours and generate a list for the antimicrobial stewardship pharmacist, who will be a member of the study team. The alerts will be audited by the pharmacist daily at a centralized location. The pharmacist will attempt to determine whether each patient is clinically stable. The validated measures of clinical stability in patients with CAP are a) resolved vital sign abnormalities (temperature, heart rate, oxygen saturation, blood pressure and respiratory rate) b) normal mental status and c) ability to eat. If the patient appears stable, the pharmacist will communicate their recommendations for de-escalation to the clinical providers via a phone call or page. The de-escalation recommendations made by the pharmacist will be based on a protocol developed by the research team.
Locations (12)
Indian River Hospital
Vero Beach, Florida, United States
Weston Hospital/Cleveland Clinic Florida
Weston, Florida, United States
Akron General Hospital
Akron, Ohio, United States
Avon Hospital
Avon, Ohio, United States
Lutheran Hospital
Cleveland, Ohio, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
Euclid Hospital
Euclid, Ohio, United States
Fairview Hospital
Fairview Park, Ohio, United States
Marymount Hospital
Garfield Heights, Ohio, United States
Hillcrest Hospital
Mayfield Heights, Ohio, United States
Medina Hospital
Medina, Ohio, United States
South Pointe Hospital
Warrensville Heights, Ohio, United States