InfectionKIPRUNNCT07211620
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
A study testing Kinetics and Absolute in people with Infection and Sepsis, run by Semmelweis University at 2 sites in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Kinetics and Absolute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesHungary
- Study dates
- 6 Nov 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary2 sites, 2 recruiting
- Not yet recruiting
Saint Margaret's Hospital
Budapest, 1032
Lóránt Csiki, +36305647189, dr.csiki.lorant@sztmargit.hu
- Recruiting
Semmelweis University, Department of Intensive Therapy
Budapest, 1082
Márton Papp, +36206663224, papp.marton@semmelweis.hu
Dilan M. Karim, +36207752933, karim.dilan@semmelweis.hu
About this study
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
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.
Read the detailed description
Appropriate antibiotic (AB) therapy is still a big challenge in intensive care units today. More than 50% of our patients are considered potentially infected, and infection alone can double mortality; however, infection is later confirmed in less than 60% of patients admitted with the initial diagnosis of sepsis. According to previous studies, at least every fifth patient in intensive care units receives unnecessary antibiotics (ABs), leading to the well-known adverse effects of ABs without any benefit. The emergence of AB resistance has been associated with 700,000 avoidable deaths in 2014, and WHO estimates that it will contribute to the death of 10 million people by 2050.
Procalcitonin (PCT) is one of the most studied inflammatory biomarkers. Several randomized controlled trials (RCTs) and their meta-analyses concluded that PCT-guided antibiotic treatment could reduce the length of AB therapy without adverse effects; moreover, it may be associated with reduced 28-day mortality, which was also confirmed by our study in 2023. Accordingly, the current sepsis guideline recommends the combined evaluation of the clinical picture and PCT when stopping AB therapy; however, it contains a weak recommendation against using PCT when starting the treatment. The latter proposition is based on three studies with a significant number of surgical patients (around 40%) in two of them, in whom the applied PCT cut-off (0.5-1 ng/ml) presumably was too low, supported by several previous studies. Therefore, the overuse of ABs was more or less hardcoded into the protocol.
Kinetics of an inflammatory biomarker can carry much more information about the host response to infection instead of a single value. In a prospective observational study by Trasy et al., early PCT kinetics (PCT change between the day of suspected infection and the previous 24 hours) predicted infection, while PCT did not change in the group of patients in whom the infection was later ruled out. Tsangaris and his colleagues measured PCT daily in critically ill patients. The investigators noted a two-fold increase in PCT levels between the day of fever onset and the previous day if the patients had an infection, while there was no difference in the PCT values if the participants had no infection.
Based on these findings, the investigators created a protocol to reduce the number of unnecessary antibiotic therapies using the kinetics of PCT.
- Being tested
- Kinetics, Absolute
- Keywords
- procalcitonin, bacterial infection, antibiotics, kinetics
- Medical subject headings
- Infections, Sepsis, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KineticsOther
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.
AbsoluteOther
According to the antibiotic protocol, starting ABs is recommended if PCT ≥ 0.5 ng/ml.
| Study group | Role | What they receive |
|---|---|---|
| Kinetics | Experimental | 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. Receives: Other: Kinetics |
| Absolute | Experimental | In the case of a new-onset infection, starting ABs is recommended depending on the actual absolute value of PCT. Receives: Other: Absolute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of unnecessary antibiotic therapy
The number of unjustified antibiotic therapies divided by the number of all therapies.
Measured: From date of enrollment until 72 hours.
Secondary outcomes (11)
Organ-support free days
Number of days alive without life support - mechanical ventilation, vasoactive therapy and renal replacement therapy.
Measured: From date of enrollment until the date of disharge of the patient from the ICU or the date of patient's death from any cause, whichever came first, assessed up to 6 months.
Lenght of stay at the intensive care unit
Number of days the patient stays at ICU
Measured: From date of enrollment until the date of discharge of patient from the ICU or the date of patient's death from any cause, whichever came first, assessed up to 6 months.
Length of stay in hospital
Number of days the patient stays in the hospital
Measured: From date of enrollment until the date of hospital discharge of the patient or the date of patient's death from any cause, whichever came first, assessed up to 6 months.
Duration of mechanical ventilation
Duration of mechanical ventilation in days
Measured: From date of enrollment until date of ICU discharge of the patient or date of patient's death from any cause, whichever came first, asessed up to 6 months.
Duration of renal replacement therapy
Duration of renal replacement therapy in days
Measured: From date of enrollment until date of hospital discharge of the patient or date of patient's death from any cause, whichever came first, assessed up to 6 months.
Duration of catecholamine circulatory support
Duration of catecholamine circulatory support in days
Measured: From date of enrollment until date of ICU discharge of the patient or date of patient's death from any cause, whichever came first, assessed up to 6 months.
ICU mortality
The number of patients died during ICU stay devided by the number of patients enrolled.
Measured: From date of enrollment until the date of ICU discharge of the patient, assessed up to 6 months.
28-day mortality
The number of patients died divided by the number of patients enrolled.
Measured: From date of enrollment until day 28.
In-hospital mortality
The number of patients died devided by the number of patients enrolled.
Measured: From date of enrollment until hospital discharge of the patient, assessed up to 6 months.
Number of Multidrug-resistant Organism caused infections
Number of diagnosed infections caused by bacteria that are resistant to one or more classes of antimicrobial agents.
Measured: From date of enrollment until the date of hospital discharge of the patient or the patient's death from any cause, whichever came first, assessed up to 6 months.
Number of Clostridioides difficile infections
Number of verified Clostridioides difficile infections
Measured: From date of enrollment until the date of hospital discharge of the patient or the patient's death from any cause, whichever came first, assessed up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start6 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Papp Márton, Semmelweis University
- Investigators
- Nikolett Kiss, Study chair, Semmelweis UniversityLászló Zubek, Study chair, Semmelweis UniversityCaner Turan, Study chair, Semmelweis UniversityDilan M. Karim, Study chair, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211620
- Sponsor's protocol ID
- BM/20019- 1/2025
- Acronym
- KIPRUN
- Status last verified
- Nov 2026
- First submitted
- 21 Sep 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data obtained through the study may be provided to researchers with an interest in optimizing antibiotic therapy of critically ill patients. Data and samples will be coded if shared with no protected health information included. Zsolt Molnár will receive invitations/requests to share individual participant data, and will consider if the request: 1) explicitly serves public benefit, 2) complies with local ethical and data security regulations of the requesting and providing institutions, 3) lays out the existing or planned legal and technical infrastructure for data transfer, 4) provides a publicly available protocol for planned statistical analyses.
Publications
Shankar-Hari M, Phillips GS, Levy ML, Seymour CW, Liu VX, Deutschman CS, Angus DC, Rubenfeld GD, Singer M; Sepsis Definitions Task Force. Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):775-87. doi: 10.1001/jama.2016.0289.
PubMed 26903336Tsangaris I, Plachouras D, Kavatha D, Gourgoulis GM, Tsantes A, Kopterides P, Tsaknis G, Dimopoulou I, Orfanos S, Giamarellos-Bourboulis E, Giamarellou H, Armaganidis A. Diagnostic and prognostic value of procalcitonin among febrile critically ill patients with prolonged ICU stay. BMC Infect Dis. 2009 Dec 22;9:213. doi: 10.1186/1471-2334-9-213.
PubMed 20028533Trasy D, Tanczos K, Nemeth M, Hankovszky P, Lovas A, Mikor A, Hajdu E, Osztroluczki A, Fazakas J, Molnar Z. Delta Procalcitonin Is a Better Indicator of Infection Than Absolute Procalcitonin Values in Critically Ill Patients: A Prospective Observational Study. J Immunol Res. 2016;2016:3530752. doi: 10.1155/2016/3530752. Epub 2016 Aug 15.
PubMed 27597981Szakmany T, Molnar Z. Procalcitonin levels do not predict mortality following major abdominal surgery. Can J Anaesth. 2003 Dec;50(10):1082-3. doi: 10.1007/BF03018387. No abstract available.
PubMed 14656802Trasy D, Tanczos K, Nemeth M, Hankovszky P, Lovas A, Mikor A, Laszlo I, Hajdu E, Osztroluczki A, Fazakas J, Molnar Z; EProK study group. Early procalcitonin kinetics and appropriateness of empirical antimicrobial therapy in critically ill patients: A prospective observational study. J Crit Care. 2016 Aug;34:50-5. doi: 10.1016/j.jcrc.2016.04.007. Epub 2016 Apr 13.
PubMed 27288610Najafi A, Khodadadian A, Sanatkar M, Shariat Moharari R, Etezadi F, Ahmadi A, Imani F, Khajavi MR. The Comparison of Procalcitonin Guidance Administer Antibiotics with Empiric Antibiotic Therapy in Critically Ill Patients Admitted in Intensive Care Unit. Acta Med Iran. 2015;53(9):562-7.
PubMed 26553084Layios N, Lambermont B, Canivet JL, Morimont P, Preiser JC, Garweg C, Ledoux D, Frippiat F, Piret S, Giot JB, Wiesen P, Meuris C, Massion P, Leonard P, Nys M, Lancellotti P, Chapelle JP, Damas P. Procalcitonin usefulness for the initiation of antibiotic treatment in intensive care unit patients. Crit Care Med. 2012 Aug;40(8):2304-9. doi: 10.1097/CCM.0b013e318251517a.
PubMed 22809906Jensen JU, Hein L, Lundgren B, Bestle MH, Mohr TT, Andersen MH, Thornberg KJ, Loken J, Steensen M, Fox Z, Tousi H, Soe-Jensen P, Lauritsen AO, Strange D, Petersen PL, Reiter N, Hestad S, Thormar K, Fjeldborg P, Larsen KM, Drenck NE, Ostergaard C, Kjaer J, Grarup J, Lundgren JD; Procalcitonin And Survival Study (PASS) Group. Procalcitonin-guided interventions against infections to increase early appropriate antibiotics and improve survival in the intensive care unit: a randomized trial. Crit Care Med. 2011 Sep;39(9):2048-58. doi: 10.1097/CCM.0b013e31821e8791.
PubMed 21572328Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.
PubMed 34605781Papp M, Kiss N, Baka M, Trasy D, Zubek L, Fehervari P, Harnos A, Turan C, Hegyi P, Molnar Z. Procalcitonin-guided antibiotic therapy may shorten length of treatment and may improve survival-a systematic review and meta-analysis. Crit Care. 2023 Oct 13;27(1):394. doi: 10.1186/s13054-023-04677-2.
PubMed 37833778de Kraker ME, Stewardson AJ, Harbarth S. Will 10 Million People Die a Year due to Antimicrobial Resistance by 2050? PLoS Med. 2016 Nov 29;13(11):e1002184. doi: 10.1371/journal.pmed.1002184. eCollection 2016 Nov.
PubMed 27898664Montravers P, Dupont H, Gauzit R, Veber B, Bedos JP, Lepape A; Club d'Infectiologie en Anesthesie-Reanimation Study Group. Strategies of initiation and streamlining of antibiotic therapy in 41 French intensive care units. Crit Care. 2011;15(1):R17. doi: 10.1186/cc9961. Epub 2011 Jan 13.
PubMed 21232098Klein Klouwenberg PM, Cremer OL, van Vught LA, Ong DS, Frencken JF, Schultz MJ, Bonten MJ, van der Poll T. Likelihood of infection in patients with presumed sepsis at the time of intensive care unit admission: a cohort study. Crit Care. 2015 Sep 7;19(1):319. doi: 10.1186/s13054-015-1035-1.
PubMed 26346055Vincent JL, Sakr Y, Singer M, Martin-Loeches I, Machado FR, Marshall JC, Finfer S, Pelosi P, Brazzi L, Aditianingsih D, Timsit JF, Du B, Wittebole X, Maca J, Kannan S, Gorordo-Delsol LA, De Waele JJ, Mehta Y, Bonten MJM, Khanna AK, Kollef M, Human M, Angus DC; EPIC III Investigators. Prevalence and Outcomes of Infection Among Patients in Intensive Care Units in 2017. JAMA. 2020 Apr 21;323(15):1478-1487. doi: 10.1001/jama.2020.2717.
PubMed 32207816Papp M, Turan C, Kiss N, Zubek L, Karim DM, Hegyi P, Molnar Z. KInetics of Procalcitonin to Reduce Unnecessary aNtibiotic use (KIPRUN): protocol for a multicentre, randomised, superiority trial to compare the efficacy and safety of procalcitonin kinetics-guided and absolute procalcitonin value-guided antibiotic initiation in critically ill patients. BMJ Open. 2026 May 13;16(5):e115344. doi: 10.1136/bmjopen-2025-115344.
PubMed 42128499
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07211620
- Acronym / sponsor ID
- KIPRUN / BM/20019- 1/2025
- Keywords
- procalcitonin, bacterial infection, antibiotics, kinetics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Appropriate antibiotic (AB) therapy is still a big challenge in intensive care units today. More than 50% of our patients are considered potentially infected, and infection alone can double mortality; however, infection is later confirmed in less than 60% of patients admitted with the initial diagnosis of sepsis. According to previous studies, at least every fifth patient in intensive care units receives unnecessary antibiotics (ABs), leading to the well-known adverse effects of ABs without any benefit. The emergence of AB resistance has been associated with 700,000 avoidable deaths in 2014, and WHO estimates that it will contribute to the death of 10 million people by 2050.
Procalcitonin (PCT) is one of the most studied inflammatory biomarkers. Several randomized controlled trials (RCTs) and their meta-analyses concluded that PCT-guided antibiotic treatment could reduce the length of AB therapy without adverse effects; moreover, it may be associated with reduced 28-day mortality, which was also confirmed by our study in 2023. Accordingly, the current sepsis guideline recommends the combined evaluation of the clinical picture and PCT when stopping AB therapy; however, it contains a weak recommendation against using PCT when starting the treatment. The latter proposition is based on three studies with a significant number of surgical patients (around 40%) in two of them, in whom the applied PCT cut-off (0.5-1 ng/ml) presumably was too low, supported by several previous studies. Therefore, the overuse of ABs was more or less hardcoded into the protocol.
Kinetics of an inflammatory biomarker can carry much more information about the host response to infection instead of a single value. In a prospective observational study by Trasy et al., early PCT kinetics (PCT change between the day of suspected infection and the previous 24 hours) predicted infection, while PCT did not change in the group of patients in whom the infection was later ruled out. Tsangaris and his colleagues measured PCT daily in critically ill patients. The investigators noted a two-fold increase in PCT levels between the day of fever onset and the previous day if the patients had an infection, while there was no difference in the PCT values if the participants had no infection.
Based on these findings, the investigators created a protocol to reduce the number of unnecessary antibiotic therapies using the kinetics of PCT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinetics | Experimental | Other: KineticsIn 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. |
| Absolute | Experimental | Other: AbsoluteIn the case of a new-onset infection, starting ABs is recommended depending on the actual absolute value of PCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.).
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KineticsInitiation 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 | Kinetics |
| AbsoluteAccording to the antibiotic protocol, starting ABs is recommended if PCT ≥ 0.5 ng/ml. | Other | Absolute |
Primary outcome
Rate of unnecessary antibiotic therapy
Time frame: From date of enrollment until 72 hours.
The number of unjustified antibiotic therapies divided by the number of all therapies.
11 secondary outcomes
Organ-support free days
Time frame: From date of enrollment until the date of disharge of the patient from the ICU or the date of patient's death from any cause, whichever came first, assessed up to 6 months.
Lenght of stay at the intensive care unit
Time frame: From date of enrollment until the date of discharge of patient from the ICU or the date of patient's death from any cause, whichever came first, assessed up to 6 months.
Length of stay in hospital
Time frame: From date of enrollment until the date of hospital discharge of the patient or the date of patient's death from any cause, whichever came first, assessed up to 6 months.
Duration of mechanical ventilation
Time frame: From date of enrollment until date of ICU discharge of the patient or date of patient's death from any cause, whichever came first, asessed up to 6 months.
Duration of renal replacement therapy
Time frame: From date of enrollment until date of hospital discharge of the patient or date of patient's death from any cause, whichever came first, assessed up to 6 months.
Duration of catecholamine circulatory support
Time frame: From date of enrollment until date of ICU discharge of the patient or date of patient's death from any cause, whichever came first, assessed up to 6 months.
ICU mortality
Time frame: From date of enrollment until the date of ICU discharge of the patient, assessed up to 6 months.
28-day mortality
Time frame: From date of enrollment until day 28.
In-hospital mortality
Time frame: From date of enrollment until hospital discharge of the patient, assessed up to 6 months.
Number of Multidrug-resistant Organism caused infections
Time frame: From date of enrollment until the date of hospital discharge of the patient or the patient's death from any cause, whichever came first, assessed up to 6 months.
Number of Clostridioides difficile infections
Time frame: From date of enrollment until the date of hospital discharge of the patient or the patient's death from any cause, whichever came first, assessed up to 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 26903336Shankar-Hari M, Phillips GS, Levy ML, Seymour CW, Liu VX, Deutschman CS, Angus DC, Rubenfeld GD, Singer M; Sepsis Definitions Task Force. Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):775-87. doi: 10.1001/jama.2016.0289.
- Background: PubMed 20028533Tsangaris I, Plachouras D, Kavatha D, Gourgoulis GM, Tsantes A, Kopterides P, Tsaknis G, Dimopoulou I, Orfanos S, Giamarellos-Bourboulis E, Giamarellou H, Armaganidis A. Diagnostic and prognostic value of procalcitonin among febrile critically ill patients with prolonged ICU stay. BMC Infect Dis. 2009 Dec 22;9:213. doi: 10.1186/1471-2334-9-213.
- Background: PubMed 27597981Trasy D, Tanczos K, Nemeth M, Hankovszky P, Lovas A, Mikor A, Hajdu E, Osztroluczki A, Fazakas J, Molnar Z. Delta Procalcitonin Is a Better Indicator of Infection Than Absolute Procalcitonin Values in Critically Ill Patients: A Prospective Observational Study. J Immunol Res. 2016;2016:3530752. doi: 10.1155/2016/3530752. Epub 2016 Aug 15.
- Background: PubMed 14656802Szakmany T, Molnar Z. Procalcitonin levels do not predict mortality following major abdominal surgery. Can J Anaesth. 2003 Dec;50(10):1082-3. doi: 10.1007/BF03018387. No abstract available.
- Background: PubMed 27288610Trasy D, Tanczos K, Nemeth M, Hankovszky P, Lovas A, Mikor A, Laszlo I, Hajdu E, Osztroluczki A, Fazakas J, Molnar Z; EProK study group. Early procalcitonin kinetics and appropriateness of empirical antimicrobial therapy in critically ill patients: A prospective observational study. J Crit Care. 2016 Aug;34:50-5. doi: 10.1016/j.jcrc.2016.04.007. Epub 2016 Apr 13.
- Background: PubMed 26553084Najafi A, Khodadadian A, Sanatkar M, Shariat Moharari R, Etezadi F, Ahmadi A, Imani F, Khajavi MR. The Comparison of Procalcitonin Guidance Administer Antibiotics with Empiric Antibiotic Therapy in Critically Ill Patients Admitted in Intensive Care Unit. Acta Med Iran. 2015;53(9):562-7.
- Background: PubMed 22809906Layios N, Lambermont B, Canivet JL, Morimont P, Preiser JC, Garweg C, Ledoux D, Frippiat F, Piret S, Giot JB, Wiesen P, Meuris C, Massion P, Leonard P, Nys M, Lancellotti P, Chapelle JP, Damas P. Procalcitonin usefulness for the initiation of antibiotic treatment in intensive care unit patients. Crit Care Med. 2012 Aug;40(8):2304-9. doi: 10.1097/CCM.0b013e318251517a.
- Background: PubMed 21572328Jensen JU, Hein L, Lundgren B, Bestle MH, Mohr TT, Andersen MH, Thornberg KJ, Loken J, Steensen M, Fox Z, Tousi H, Soe-Jensen P, Lauritsen AO, Strange D, Petersen PL, Reiter N, Hestad S, Thormar K, Fjeldborg P, Larsen KM, Drenck NE, Ostergaard C, Kjaer J, Grarup J, Lundgren JD; Procalcitonin And Survival Study (PASS) Group. Procalcitonin-guided interventions against infections to increase early appropriate antibiotics and improve survival in the intensive care unit: a randomized trial. Crit Care Med. 2011 Sep;39(9):2048-58. doi: 10.1097/CCM.0b013e31821e8791.
- Background: PubMed 34605781Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.
- Background: PubMed 37833778Papp M, Kiss N, Baka M, Trasy D, Zubek L, Fehervari P, Harnos A, Turan C, Hegyi P, Molnar Z. Procalcitonin-guided antibiotic therapy may shorten length of treatment and may improve survival-a systematic review and meta-analysis. Crit Care. 2023 Oct 13;27(1):394. doi: 10.1186/s13054-023-04677-2.
- Background: PubMed 27898664de Kraker ME, Stewardson AJ, Harbarth S. Will 10 Million People Die a Year due to Antimicrobial Resistance by 2050? PLoS Med. 2016 Nov 29;13(11):e1002184. doi: 10.1371/journal.pmed.1002184. eCollection 2016 Nov.
- Background: PubMed 21232098Montravers P, Dupont H, Gauzit R, Veber B, Bedos JP, Lepape A; Club d'Infectiologie en Anesthesie-Reanimation Study Group. Strategies of initiation and streamlining of antibiotic therapy in 41 French intensive care units. Crit Care. 2011;15(1):R17. doi: 10.1186/cc9961. Epub 2011 Jan 13.
- Individual participant dataSharing planned: Yes. All data obtained through the study may be provided to researchers with an interest in optimizing antibiotic therapy of critically ill patients. Data and samples will be coded if shared with no protected health information included. Zsolt Molnár will receive invitations/requests to share individual participant data, and will consider if the request: 1) explicitly serves public benefit, 2) complies with local ethical and data security regulations of the requesting and providing institutions, 3) lays out the existing or planned legal and technical infrastructure for data transfer, 4) provides a publicly available protocol for planned statistical analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikolett Kiss study chair
Semmelweis University
László Zubek study chair
Semmelweis University
Caner Turan study chair
Semmelweis University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinetics and Absolute in people with Infection and Sepsis, run by Semmelweis University at 2 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Márton Papp (+36206663224, papp.marton@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of unnecessary antibiotic therapy (time frame: From date of enrollment until 72 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07211620, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.