Procalcitonin Aided Antimicrobial Therapy vs Standard of Care

NCT ID: NCT06960044

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-06-01

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.

Detailed Description

Antibiotic resistance (ABR) poses a significant threat to global health and is largely driven by the overuse of antibiotics, particularly for acute respiratory tract infections (ARTIs), which are mostly viral. Despite this, antibiotics are frequently prescribed, often for unnecessarily long durations due to the lack of reliable markers indicating illness resolution. This has led to an interest in using biomarkers like procalcitonin (PCT) to guide antibiotic therapy more accurately.

PCT is a precursor of the hormone calcitonin and increases significantly in the presence of bacterial infections, offering a promising tool for distinguishing bacterial from viral infections and for monitoring infection progression and response to treatment. It rises within hours of infection onset, peaks by day two, and decreases with recovery, making it useful for deciding when to start or stop antibiotics.

Clinical studies, including the large PRORATA randomized controlled trial, have demonstrated that PCT-guided antibiotic protocols are safe and effective in reducing antibiotic use without compromising patient outcomes. A Cochrane review further supported this, showing that PCT-guided therapy reduces mortality, antibiotic consumption, and antibiotic-related adverse effects in patients with ARTIs.

However, PCT testing has yet to be widely adopted in hospitals due to concerns about its cost-effectiveness and implementation challenges. To address these concerns, a series of health economic evaluations have been carried out: they assess the clinical and economic impact of PCT-guided therapy, particularly its role in reducing complications such as ABR and Clostridium difficile infections (CDI).

Findings consistently show that PCT-guided antibiotic therapy not only improves patient outcomes but also reduces direct healthcare costs when compared to standard care. Recent modeling incorporating RWE from a U.S. hospital further confirmed these benefits in real-world settings, strengthening the case for broader adoption of PCT in hospital-based antibiotic stewardship programs.

Conditions

Lower Respiratory Tract Infection (LRTI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Procalcitonin-guided antibiotic management

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

Group Type: EXPERIMENTAL

Procalcitonin-guided antibiotic management

Intervention Type: 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.

Standard of care

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

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: 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.

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thermo Fisher Scientific FS

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Center

Alessandria, Piedmont, Italy

Countries

Italy

Central Contacts

Prof. Luigi Mario Castello

Role: CONTACT

luigi.castello@ospedale.al.it

0131206893

Facility Contacts

Clinical Trial Center

Role: primary

clinicaltrialcenter@ospedale.al.it

0131206893

Other Identifiers

ASO.MedI.24.02

Identifier Type: -

Identifier Source: org_study_id