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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

ConditionsInfectionSepsis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSemmelweis University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Kinetics

    Other intervention

    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.

  • Absolute

    Other intervention

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

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: KineticsExperimental treatment 1 intervention
Group B: AbsoluteExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of unnecessary antibiotic therapy

The number of unjustified antibiotic therapies divided by the number of all therapies.

Time frame
From date of enrollment until 72 hours.

Secondary outcomes

1

Organ-support free days

Number of days alive without life support - mechanical ventilation, vasoactive therapy and renal replacement therapy.

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.
2

Lenght of stay at the intensive care unit

Number of days the patient stays at ICU

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.
3

Length of stay in hospital

Number of days the patient stays in the 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.
4

Duration of mechanical ventilation

Duration of mechanical ventilation in days

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Semmelweis University

Lead sponsor

Source ClinicalTrials.gov
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