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Procalcitonin Aided Antimicrobial Therapy vs Standard of Care
Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Summary
Antibiotic resistance is driven by overuse, especially for viral respiratory infections. Procalcitonin (PCT), a biomarker for bacterial infections, helps guide antibiotic therapy more precisely, reducing unnecessary use and improving outcomes. Studies, including large trials and economic models across several countries, show PCT-guided treatment lowers mortality, antibiotic exposure, therapy duration and related complications, potentially reducing hospital costs despite initial testing expenses.
Official title: Procalcitonin Aided Antimicrobial Therapy vs Standard of Care: a Randomized Prospective Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2025-06-01
Completion Date
2027-06-01
Last Updated
2025-05-07
Healthy Volunteers
No
Conditions
Interventions
Procalcitonin-guided antibiotic management
After the randomization, PCT plasma concentration will be dosed and repeated every 24 hours and antimicrobial treatment will be withdrawn as soon as the PCT value will decrease \> 80% of peak value or will fall below 0.25 ng/mL. Patients with a normal baseline PCT value (below 0.25 ng/mL) will start the antimicrobial therapy, as clinically appropriate and PCT plasma concentration will be repeated every 24 hours, as indicated in the protocol. The antimicrobial agents will be managed according to the clinical and radiological evolution of the LRTI.
Standard of care
Patients assigned to the control group will be treated according to the best standard of care and PCT will not be evaluated for the whole duration of the study.
Locations (1)
Clinical Trial Center
Alessandria, Piedmont, Italy