Actively Recruiting
KInetics of Procalcitonin to Reduce Unnecessary aNtibiotic Use - Comparing Procalcitonin Kinetics-guided and Absolute Procalcitonin Value-guided Antibiotic Initiation in Reducing Unnecessary Antibiotic Use in Critically Ill Patients
Led by Semmelweis University · Updated on 2026-01-09
250
Participants Needed
2
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study aims to compare the efficacy and safety of an absolute procalcitonin (PCT) value-guided antibiotic initiation protocol and a protocol using the kinetics of PCT (the difference between the actual and the previous day value) in hemodynamically stable critically ill patients with suspected new-onset infection on admission or during ICU stay. The main question it aims to answer: * Can the investigators decrease the number of unnecessary AB therapies using the kinetics of PCT insted of using absolute PCT values? * Is it safe to use PCT kinetics together with the clinical picture to guide AB initiation? AB therapy will be initiated according to predefined PCT protocols (Kinetics and Absolute Group). After 72 hours of treatment, an independent multidisciplinary team (infectologist, microbiologist and intensivist) will decide about the necessity of the treatment with all the relevant results in hand.
CONDITIONS
Official Title
KInetics of Procalcitonin to Reduce Unnecessary aNtibiotic Use - Comparing Procalcitonin Kinetics-guided and Absolute Procalcitonin Value-guided Antibiotic Initiation in Reducing Unnecessary Antibiotic Use in Critically Ill Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Non-surgical, surgical, or trauma patients
- Suspected new-onset infection at admission or during ICU stay
- Known or highly suspected infection source with source control implemented if needed
- Two procalcitonin values available: one on the day of suspected infection and one 24 ± 4 hours earlier
- Microbiology sampling performed according to presumed infection sources
- Written informed consent provided by patient or legal guardian
You will not qualify if you...
- Septic shock requiring vasopressors and with serum lactate >2 mmol/L after fluids
- Infections needing long-term antibiotic treatment (e.g., infective endocarditis, osteoarticular infections, chronic prostatitis, tuberculosis)
- Infections related to surgical interventions without guaranteed source control (e.g., fecal peritonitis, pancreatic necrosectomy, necrotizing fasciitis)
- Indisputable infections such as hepatic abscess or empyema
- Expected ICU stay less than 24 hours or APACHE II score over 30
- Admission after cardiopulmonary resuscitation
- Severe immunosuppression other than steroid use
- Stem-cell or solid organ transplant recipients
- HIV infection with CD4 count below 200 cells/mm3
- Neutropenia with fewer than 500 neutrophils/mm3
- Antibiotic use within 72 hours before inclusion
- Pregnancy or breastfeeding; women of childbearing age must have a negative pregnancy test before inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Saint Margaret's Hospital
Budapest, Hungary, 1032
Not Yet Recruiting
2
Semmelweis University, Department of Intensive Therapy
Budapest, Hungary, 1082
Actively Recruiting
Research Team
M
Márton Papp
CONTACT
Z
Zsolt Molnár
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here