PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pneumonia, Bacterial
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 700
- Locations
- 6
- Primary Endpoint
- Short Treatment of Pneumonia
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Trials comparing PCT-guided antibiotic algorithms to standard management show a significant reduction in antibiotic exposure without an increase in mortality or treatment failure. Despite this strong evidence from multiple studies a recent prospective multicentric interventional trial in the US fell short of demonstrating antibiotic reductions by PCT-guided antibiotic management. Amongst other limitations the authors of that study concluded that successful implementation of PCT may require closer educational oversight. As such, this study will compare effectiveness and safety of antibiotic prescription guided by a PCT-algorithm via a Stewardship Team over standard guidelines in hospitalized adult patients with suspected or confirmed LRTI (including sepsis with respiratory focus).
Investigators
Michael K. Mansour
Assistant Professor of Medicine
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Hospitalized adult patients ≥ 18 years of age
- •Suspected or confirmed pneumonia \<28 days at time of admission to the hospital (ED) who are prescribed antibiotics
- •Minimum of 2 (two) blood samples available for PCT value assessment within 24 hours of hospitalization
Exclusion Criteria
- •Patient has tested positive for SARS-CoV-2
- •Non-hospitalized patients
- •Patients admitted to home health
- •Major surgeries, defined as any procedure in which an incision is made with the exception of superficial procedures (eyes, cornea, skin, dental procedures), organs removed, or normal anatomy altered (e.g. open thoracic, abdominal and/or major orthopedic surgery), in the past 1 month or expected surgical procedure or patient receiving antibiotics for surgical prophylaxis
- •Active metastatic cancer or neuroendocrine tumor or liquid tumor and/or on check point inhibitors within 3 months or has signs of mucositis (e.g. mouth lesions or intestinal bleeding)
- •Known pregnancy
- •Primary and acquired cell-mediated immune deficiency (HIV with CD4 \<350 cells/mm³; receipt of systemic chemotherapy and/or biologics in the past 3 months for reasons other than malignancy)
- •Infection where long course antibiotics are the standard of care(\>2 weeks) other than anti-inflammatory reasons.
- •Neutropenia (\<1,500 ANC)
- •Concomitant non-pulmonary bacterial infection that requires antibiotic therapy based on an active medical team decision
Outcomes
Primary Outcomes
Short Treatment of Pneumonia
Time Frame: 30 days
Proportion of patients with short treatment of pneumonia with antibiotics (less than 4 days, "shortABx")
Secondary Outcomes
- Composite Safety Adverse Event Rate(30 days)
- Antibiotic Exposure at Discharge(30 days)
- Days of Therapy Per 1000 Patient Days(30 days)
- Length of Stay(30 days)
- ICU Admissions(30 days)