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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

NCT07211620 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-01-09

No results posted yet for this study

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 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.

Conditions

Interventions

OTHER

Kinetics

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.

OTHER

Absolute

According to the antibiotic protocol, starting ABs is recommended if PCT ≥ 0.5 ng/ml.

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Principal Investigators

  • Nikolett Kiss · Semmelweis University

  • László Zubek · Semmelweis University

  • Caner Turan · Semmelweis University

  • Dilan M. Karim · Semmelweis University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-06
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Hungary

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07211620 on ClinicalTrials.gov