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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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Hungary
Saint Margaret's Hospital
NOT_YET_RECRUITING
Budapest
Semmelweis University, Department of Intensive Therapy
RECRUITING
Budapest
Contact Information
Primary
Márton Papp
papp.marton@semmelweis.hu
+36206663224
Backup
Zsolt Molnár
molnar.zsolt1@semmelweis.hu
+36303026668
Time Frame
Start Date: 2025-11-06
Estimated Completion Date: 2027-12
Participants
Target number of participants: 250
Treatments
Experimental: Kinetics
In the case of a suspected new-onset infection, the treating physician starts antibiotic therapy according to a predefined protocol depending on the kinetics of PCT.
Experimental: Absolute
In the case of a new-onset infection, starting ABs is recommended depending on the actual absolute value of PCT.
Related Therapeutic Areas
Sponsors
Leads: Semmelweis University

This content was sourced from clinicaltrials.gov