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

NCT07211620 NA RECRUITING

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.

Details

Lead sponsor	Semmelweis University
Phase	NA
Status	RECRUITING
Enrolment	250
Start date	2025-11-06
Completion	2027-12

Conditions

• Infection
• Sepsis

Interventions

• Kinetics
• Absolute

Primary outcomes

• Rate of unnecessary antibiotic therapy — From date of enrollment until 72 hours.
  The number of unjustified antibiotic therapies divided by the number of all therapies.

Countries

Hungary