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Compares treatment options for Infection
Official title 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
ClinicalTrials.gov ID: NCT07211620
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- Septic shock (hypotension requiring vasopressor therapy to maintain mean blood pressure of 65 mmHg or greater and having a serum lactate level...
- Infections for which long-term antibiotic treatment is strongly recommended (e.g., infective endocarditis, osteoarticular infections, chronic...
- Infections related to primary surgical intervention and adequate source control cannot be guaranteed (e.g., fecal peritonitis, pancreatic...
- 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
See the full eligibility 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Budapest, Hungary
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Budapest, Hungary. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.