Using procalcitonin changes versus single procalcitonin values to reduce unnecessary antibiotics in ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Semmelweis University, Department of Intensive Therapy
  Budapest, Hungary Recruiting
• Saint Margaret's Hospital
  Budapest, Hungary Not yet recruiting

Study contacts

• Study coordinator: Márton Papp
• Email: papp.marton@semmelweis.hu
• Phone: +36206663224

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.