Procalcitonin Aided Antimicrobial Therapy vs Standard of Care

NCT06960044 | Not Yet Recruiting

• 1 other identifier: ASO.MedI.24.02
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Respiratory Tract Infection (LRTI)

Keywords

procalcitonin; procalcitonin-guided antibiotic management

Outcome Measures

Primary Outcomes (1)

• Duration of antimicrobial treatment

  Measure of the antimicrobial treatment duration in days

  Periprocedural

Secondary Outcomes (8)

• Length of hospital stay

  Periprocedural

• Sequential Organ Failure Assessment

  At baseline and every 24 hours

• Quick Sequential Organ Failure Assessment

  At baseline

• National Early Warning Score

  At baseline and every 24 hours

• Incidence of Clostridium difficile infections (CDI)

  Periprocedural

Study Arms (2)

Procalcitonin-guided antibiotic management

EXPERIMENTAL

Patients hospitalized in Internal Medicine, Geriatrics, Infectious Disease unit, Pneumology, Semi Intensive Care unit, ICU, Emergency Medicine with clinical and instrumental diagnosis of lower respiratory tract infection (LRTI), randomized in the experimental arm

Procedure: Procalcitonin-guided antibiotic management

Standard of care

ACTIVE COMPARATOR

Patients hospitalized in Internal Medicine, Geriatrics, Infectious Disease unit, Pneumology, Semi Intensive Care unit, ICU, Emergency Medicine with clinical and instrumental diagnosis of lower respiratory tract infection (LRTI), randomized in the control arm

Procedure: Standard of care

Interventions

Procalcitonin-guided antibiotic management PROCEDURE

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randomization, PCT plasma concentration will be dosed and repeated every 24 hours and antimicrobial treatment will be withdrawn as soon as the PCT value will decrease \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

Procalcitonin-guided antibiotic management

Standard of care PROCEDURE

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.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead
• Thermo Fisher Scientific FS: collaborator

Study Sites (1)

Clinical Trial Center

Alessandria, Piedmont, 15121, Italy

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Prof. Luigi Mario Castello

CONTACT

0131206893; luigi.castello@ospedale.al.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, randomized, two-arm with a 1:1 ratio study

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 7, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

IT (1)