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Starting soon Not applicable

Procalcitonin Aided Antimicrobial Therapy vs Standard of Care

NCT06960044 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-06-01
Last updated
2025-05-07

Condition(s) studied

Lower Respiratory Tract Infection (LRTI)

Investigational drug(s) / intervention(s)

Procalcitonin-guided antibiotic managementStandard of care

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randomization, PCT plasma concentration will be dosed and repeated every 24 hours and antimicrobial treatment will be withdrawn as soon as the PCT value will decrease \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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * age ≥18 years; * clinical and instrumental diagnosis of LRTI consistent with bacterial origin and requiring antimicrobial treatment; * patient hospitalized in Internal Medicine, Geriatrics, Infectious Disease unit, Pneumology, Semi Intensive Care unit, ICU, Emergency Medicine; * informed consent provided by the patient. Exclusion Criteria: * age \< 18 years; * lack of informed consent; * severe immunosuppression (other than related to corticosteroid use); * concomitant diagnosis of other infections requiring long term antimicrobial therapy (i.e. endocarditis, osteomyelitis)

Primary outcome measure(s)

  • Duration of antimicrobial treatment — Periprocedural
    Measure of the antimicrobial treatment duration in days

Trial sites (1)

FacilityCityRegionStatus
Clinical Trial Center Alessandria Piedmont
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06960044 on ClinicalTrials.gov ↗ ← All trials in Italy