CompletedNCT02294695Updated Jun 17, 2016

Early Procalcitonin Kinetics During Empirical Antibiotic Therapy in Critically Ill Patients

An observational study in Bacterial Infections, sponsored by Domonkos Trásy. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-17.

Sponsored by Domonkos Trásy · Observational

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 209
Ages: 18 Years and older
Sex: All

Study summary

To investigate the value of procalcitonin (PCT) kinetics between 0-8-16-24 hours after starting empirical antibiotic therapy in critically ill patients, to predict appropriate or inappropriate antibiotic treatment.

Conditions studied

Bacterial Infections

Browse trials for

Bacterial Infections 658

Keywords

Empiric antibiotic therapy

In context

Bacterial Infections

658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.

This study's enrollment of 209 is close to the median of 200 across 229 observational studies indexed under Bacterial Infections.

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Lead sponsor

Domonkos Trásy is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

All patients over 18 years with suspected infection on admission or during their stay on the intensive care unit were screened for eligibility. Patients were enrolled, when the attending intensive care specialist had a suspicion of infection and decided to start empirical antibiotic therapy.

Inclusion criteria

Clinical signs of infection
Suspected or proven acute infection requiring empiric antibiotic therapy as decided by the attending ICU physician
Suspected site of infection has to be present and documented
Microbiological sample sent for staining
Inflammatory markers available at the start of the therapy

Exclusion criteria

Exclusion Criteria:

Patients younger than 18 years
Who received prophylactic or empiric antibiotic therapy 48 hours before inclusion
Whose receiving acute renal replacement therapy in the first 24 hours following antibiotic treatment
Following cardiopulmonary resuscitation
End stage diseases with a "do not resuscitate" order
Immunocompromised patients (human immunodeficiency virus infection, bone marrow transplantation, malignant haematological disorders and chemotherapy)
Post cardiac surgery patients

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 209 participants (actual)
Patient registry: No

Groups and cohorts

Appropriate empiric antibiotic therapy
Based on the microbiological results patients were grouped post hoc into "appropriate" and "inappropriate" groups by two independent experts (intensivist, infectologist) who were blinded for PCT.
Inappropriate empiric antibiotic therapy
Based on the microbiological results patients were grouped post hoc into "appropriate" and "inappropriate" groups by two independent experts (intensivist, infectologist) who were blinded for PCT.

What researchers measure

Primary outcomes

Procalcitonin kinetic
PCT levers are measured every 8 hours in the first day after starting empiric antibiotic treatment then daily and the changes in percentage are followed form the baseline value measured right before the first exposition of the antibiotic therapy.
Time frame: The first six days after starting empiric antibiotic treatment

Secondary outcomes

Sequential Organ Failure Assessment score
SOFA score is measured every day after starting empiric antibiotic treatment.
Time frame: The first six days after starting empiric antibiotic treatment

Other outcomes

Length of Intensive Care Unit stay
Time frame: Maximum 90 days after enrollment
Intensive Care Unit mortality
Time frame: Maximum 90 days after enrollment
Length of hospital stay
Time frame: Maximum 90 days after enrollment
Hospital mortality
Time frame: Maximum 90 days after enrollment

Study locations

1 site

Department of Anaesthesiology and Intensive Therapy
Szeged, Csongrád H-6725, Hungary

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02294695
Lead sponsor: Domonkos Trásy
Responsible party: Domonkos Trásy (Ph.D. student; Department of Anaesthesiology and Intensive Therapy, Szeged University) — Sponsor-investigator
First posted: Nov 19, 2014
Start date: Oct 2012
Primary completion: Oct 2013
Completion: Oct 2013
Last update: Jun 17, 2016

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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