Procalcitonin Aided Antimicrobial Therapy vs Standard of Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Procalcitonin-guided antibiotic management, Standard of care.
- Who it may be relevant to
- Registry conditions: Lower Respiratory Tract Infection (LRTI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Procalcitonin Aided Antimicrobial Therapy vs Standard of Care: a Randomized Prospective Clinical Trial
Overview
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.
Interventions
- Procedure 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 - 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.
Primary outcome measures
- Duration of antimicrobial treatment [Time frame: Periprocedural]
Secondary outcome measures (8)
- Length of hospital stay [Time frame: Periprocedural]
- Sequential Organ Failure Assessment [Time frame: At baseline and every 24 hours]
- Quick Sequential Organ Failure Assessment [Time frame: At baseline]
- National Early Warning Score [Time frame: At baseline and every 24 hours]
- Incidence of Clostridium difficile infections (CDI) [Time frame: Periprocedural]
- Incidence of multi-drug resistance (MDR) infections [Time frame: In the next 30 days after the baseline]
- Mortality [Time frame: During the study, 4 weeks and 3 months from baseline]
- Costs [Time frame: Periprocedural]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Italy · 1 center
- Clinical Trial Center — Alessandria
Identifiers
NCT: NCT06960044 · ASO.MedI.24.02