Status:
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
Lead Sponsor:
Semmelweis University
Conditions:
Infection
Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ac...
Detailed Description
Appropriate antibiotic (AB) therapy is still a big challenge in intensive care units today. More than 50% of our patients are considered potentially infected, and infection alone can double mortality;...
Eligibility Criteria
Inclusion
- Adult (18 years \< ) non-surgical, surgical, or trauma patients
- Suspected new-onset infection on admission or during ICU stay
- The source of infection is known or highly suspected, and source control has been implemented if needed (i.e., removal of an infected device (e.g., central line, endoprosthesis)
- Two PCT values are available - one on the day of suspicion of infection and one 24±4 hours earlier.
- Microbiology sampling has to be performed (according to all presumed sources - blood culture -aerobic and anaerobic, lower respiratory tract sample (tracheal aspirate/bronchoalveolar lavage), urine, etc.).
- Written informed consent of the patient (or legal guardian if the patient cannot provide consent)
Exclusion
- Septic shock (hypotension requiring vasopressor therapy to maintain mean blood pressure of 65 mmHg or greater and having a serum lactate level greater than 2 mmol/L after adequate fluid resuscitation)
- Infections for which long-term antibiotic treatment is strongly recommended (e.g., infective endocarditis, osteoarticular infections, chronic prostatitis, tuberculosis)
- Infections related to primary surgical intervention and adequate source control cannot be guaranteed (e.g., fecal peritonitis, pancreatic necrosectomy, infective necrotizing fascitis - i.e., Fournier's gangrene),
- Indisputable infections (e.g., hepatic abscess, empyema)
- Poor chance of survival (i.e., expected ICU stay less than 24 hours or initial Acute Physiology and Health Evaluation Score II (APACHE II) \>30)
- Admissions after cardiopulmonary resuscitation
- Severe immunosuppression other than steroid use
- stem-cell transplant recipients
- solid organ transplant patients
- HIV infection with a CD4 count of less than 200 cells/mm3
- Neutropenia with less than 500 neutrophils/mm3
- Patients on ABs within 72 hours before inclusion
- Patients in pregnancy or breastfeeding. Women of childbearing age will be screened by a urine pregnancy test before inclusion in the study.
Key Trial Info
Start Date :
November 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT07211620
Start Date
November 6 2025
End Date
December 1 2027
Last Update
January 9 2026
Active Locations (2)
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1
Saint Margaret's Hospital
Budapest, Hungary, 1032
2
Semmelweis University, Department of Intensive Therapy
Budapest, Hungary, 1082