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

Recruiting now · Not applicable

Conditions studied: Infection, Sepsis

In brief

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.

Key facts

Study ID: NCT07211620
Run by: Semmelweis University
People needed: 250
Starts: 2025-11-06
Expected to finish: 2027-12-01
Last updated by the study team: 2026-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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.

Where it is running

Semmelweis University, Department of Intensive Therapy — Budapest, Hungary (enrolling)
Saint Margaret's Hospital — Budapest, Hungary

Full record on ClinicalTrials.gov

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