Health TrialsbyHealthPanel

Procalcitonin Aided Antimicrobial Therapy vs Standard of Care

ConditionLower Respiratory Tract Infection (LRTI)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Procalcitonin-guided antibiotic management

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randomization, PCT plasma concentration will be dosed and repeated every 24 hours and antimicrobial treatment will be withdrawn as soon as the PCT value will decrease \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

    Procedure/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.

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Procalcitonin-guided antibiotic managementExperimental treatment 1 intervention
Group B: Standard of careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Duration of antimicrobial treatment

Measure of the antimicrobial treatment duration in days

Time frame
Periprocedural

Secondary outcomes

1

Length of hospital stay

Measure of the hospital stay in days

Time frame
Periprocedural
2

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.

Time frame
At baseline and every 24 hours
3

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.

Time frame
At baseline
4

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)).

Time frame
At baseline and every 24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Thermo Fisher Scientific FS

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: