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RECRUITING

NCT07211620

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

Sponsor: Semmelweis University

View on ClinicalTrials.gov

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 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.

Official title: KInetics of Procalcitonin to Reduce Unnecessary aNtibiotic Use (KIPRUN) - Protocol for a Multi-center, Randomized, Superiority Trial to Compare the Efficacy and Safety of Procalcitonin Kinetics-guided and Absolute Procalcitonin Value-guided Antibiotic Initiation in Reducing Unnecessary Antibiotic Therapy in Critically Ill Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2025-11-06

Completion Date

2027-12

Last Updated

2026-01-09

Healthy Volunteers

Conditions

Infection Sepsis

Interventions

OTHER

Kinetics

Initiation of the AB therapy is recommended for the clinician if PCT ≥ 0.5 ng/ml and PCT elevation ≥100% from the previous day's value.

OTHER

Absolute

According to the antibiotic protocol, starting ABs is recommended if PCT ≥ 0.5 ng/ml.

Inclusion Criteria: * 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 Criteria: * 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.

Locations (2)

Saint Margaret's Hospital

Budapest, Hungary

Semmelweis University, Department of Intensive Therapy