Lower Respiratory Tract Infection (LRTI)PCTNCT06960044
Procalcitonin Aided Antimicrobial Therapy vs Standard of Care
A study testing Procalcitonin-guided antibiotic management in people with Lower Respiratory Tract Infection (LRTI), run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Respiratory Tract Infection (LRTI)
- What is being tested?
- Procalcitonin-guided antibiotic management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Clinical Trial Center
Alessandria, Piedmont, 15121
Clinical Trial Center, 0131206893, clinicaltrialcenter@ospedale.al.it
About this study
Official title: Procalcitonin Aided Antimicrobial Therapy vs Standard of Care: a Randomized Prospective Clinical Trial
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.
Read the 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)
- Being tested
- Procalcitonin-guided antibiotic management, Standard of care
- Keywords
- procalcitonin, procalcitonin-guided antibiotic management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procalcitonin-guided antibiotic managementProcedure or surgery
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 careProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of antimicrobial treatment
Measure of the antimicrobial treatment duration in days
Measured: Periprocedural
Secondary outcomes (8)
Length of hospital stay
Measure of the hospital stay in days
Measured: Periprocedural
Sequential Organ Failure Assessment
Assessment of clinical outcome with the SOFA Score, based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Score ranges from 0 (best) to 24 (worst) points.
Measured: At baseline and every 24 hours
Quick Sequential Organ Failure Assessment
Assessment of clinical outcome with the qSOFA Score, a simplified version of the SOFA Score. Score ranges from 0 (best) to 3 (worst) points.
Measured: At baseline
National Early Warning Score
Assessment of clinical outcome with the NEWS Score, which identifies three alert levels with their specific clinical responses depending on the degree of criticality in relation to the final score derived (from 0 (code green) to 6 (code red)).
Measured: At baseline and every 24 hours
Incidence of Clostridium difficile infections (CDI)
Measure of the incidence of CDI with stool tests and GHD tests
Measured: Periprocedural
Incidence of multi-drug resistance (MDR) infections
Measure of the incidence of MDR infections
Measured: In the next 30 days after the baseline
Mortality
Mortality evaluation
Measured: During the study, 4 weeks and 3 months from baseline
Costs
Evaluation of the costs associated with antibiotic therapy and hospitalization, relative to ABR per patient with LRTI and relative to CDI per patient with LRTI
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Respiratory Tract Infection (LRTI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, randomized, two-arm with a 1:1 ratio study
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Collaborators
- Thermo Fisher Scientific FS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960044
- Sponsor's protocol ID
- ASO.MedI.24.02
- Acronym
- PCT
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin Aided Antimicrobial Therapy vs Standard of Care: a Randomized Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06960044
- Acronym / sponsor ID
- PCT / ASO.MedI.24.02
- Conditions
- Lower Respiratory Tract Infection (LRTI)
- Keywords
- procalcitonin, procalcitonin-guided antibiotic management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Collaborators
- Thermo Fisher Scientific FS
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, randomized, two-arm with a 1:1 ratio study
| Arm | Type | Receives |
|---|---|---|
| Procalcitonin-guided antibiotic management | Experimental | Procedure: Procalcitonin-guided antibiotic managementPatients 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 |
| Standard of care | Active comparator | Procedure: Standard of carePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procalcitonin-guided antibiotic managementAfter 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. | Procedure or surgery | Procalcitonin-guided antibiotic management |
| Standard of carePatients 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. | Procedure or surgery | Standard of care |
Primary outcome
Duration of antimicrobial treatment
Time frame: Periprocedural
Measure of the antimicrobial treatment duration in days
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procalcitonin-guided antibiotic management in people with Lower Respiratory Tract Infection (LRTI), run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Luigi Mario Castello (0131206893, luigi.castello@ospedale.al.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of antimicrobial treatment (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.