New study aims to cut unnecessary antibiotics in ICU patients
NCT ID NCT07211620
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using changes in procalcitonin levels over time (kinetics) is better than a single measurement for deciding when to start antibiotics in critically ill patients with suspected infection. About 250 adults in the ICU will be randomly assigned to one of two groups. The goal is to reduce unnecessary antibiotic use while ensuring patient safety.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Saint Margaret's Hospital
NOT_YET_RECRUITINGBudapest, 1032, Hungary
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Semmelweis University, Department of Intensive Therapy
RECRUITINGBudapest, 1082, Hungary
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- A routine calcium reading could reveal how sick a sepsis patient really is