Clinical trial NCT06960044: Procalcitonin Aided Antimicrobial Therapy vs Standard of Care
Official title: Procalcitonin Aided Antimicrobial Therapy vs Standard of Care: a Randomized Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lower Respiratory Tract Infection (LRTI)
Keywords: procalcitonin
procalcitonin-guided antibiotic management
Lead sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Sponsor class: OTHER
Collaborators: name: Thermo Fisher Scientific FS
First posted: 2025-05-07
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, randomized, two-arm with a 1:1 ratio study
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Duration of antimicrobial treatment
timeFrame: Periprocedural
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Periprocedural
measure: Sequential Organ Failure Assessment
timeFrame: At baseline and every 24 hours
measure: Quick Sequential Organ Failure Assessment
timeFrame: At baseline
measure: National Early Warning Score
timeFrame: At baseline and every 24 hours
measure: Incidence of Clostridium difficile infections (CDI)
timeFrame: Periprocedural
measure: Incidence of multi-drug resistance (MDR) infections
timeFrame: In the next 30 days after the baseline
measure: Mortality
timeFrame: During the study, 4 weeks and 3 months from baseline
measure: Costs
timeFrame: Periprocedural
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Clinical Trial Center
state: Piedmont
Study officials:
References: