Using procalcitonin changes versus single procalcitonin values to reduce unnecessary antibiotics in ICU patients
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
We will try to see if using daily changes in procalcitonin instead of a single procalcitonin cutoff can safely reduce unnecessary antibiotics in critically ill patients with suspected infection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Semmelweis University Academic / other |
| Locations | 2 sites (Budapest and 1 other locations) |
| Trial ID | NCT07211620 on ClinicalTrials.gov |
What this trial studies
Hemodynamically stable adult ICU patients with suspected new-onset infection who have two recent procalcitonin (PCT) measurements are assigned to one of two predefined antibiotic-initiation protocols: one based on an absolute PCT value and the other based on the 24-hour change (kinetics) in PCT. All participants undergo standard microbiological sampling and source control as indicated, and antibiotic decisions are made according to the assigned PCT protocol combined with the clinical picture. After 72 hours of treatment an independent multidisciplinary team reviews clinical and microbiology results to decide on ongoing therapy. The study compares antibiotic use and safety outcomes between the two guidance approaches.
Who should consider this trial
Good fit: Adults in the ICU who are hemodynamically stable with suspected new-onset infection and who have two PCT measurements taken about 24 hours apart are ideal candidates.
Not a fit: Patients in septic shock or those with infections expected to require long-term antibiotic therapy are unlikely to benefit from this PCT-guided initiation approach.
Why it matters
Potential benefit: If successful, this approach could lower unnecessary antibiotic exposure and its harms (side effects and resistance) while preserving patient safety.
How similar studies have performed: Previous randomized trials have shown that PCT-guided strategies can safely shorten antibiotic duration, but using PCT kinetics to guide the start of antibiotics is less studied and remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Budapest and 1 other locations
- Saint Margaret's Hospital — Budapest, Hungary (Not_yet_recruiting)
- Semmelweis University, Department of Intensive Therapy — Budapest, Hungary (Recruiting)
Study contacts
- Study coordinator: Márton Papp
- Email: papp.marton@semmelweis.hu
- Phone: +36206663224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.