Life sciences · Interventional Study
ClinicalTrials.gov · November 3, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07211620). This is a study registration, not published results. Lead sponsor: Semmelweis University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 250 participants (ESTIMATED). Conditions: Infection, Sepsis. Interventions: OTHER: Kinetics; OTHER: Absolute. Primary outcome measures: Rate of unnecessary antibiotic therapy , From date of enrollment until 72 hours.. 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 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.