Early Procalcitonin Kinetics During Empirical Antibiotic Therapy in Critically Ill Patients

Study Overview
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Brief Summary
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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.

Official Title
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Early Procalcitonin Kinetics May Indicate Effectiveness of the Empirical Antibiotic Therapy in Sepsis Within Hours

Conditions
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Bacterial Infections

Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Appropriate empiric antibiotic therapy<br>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<br>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 is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The first six days after starting empiric antibiotic treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequential Organ Failure Assessment score | SOFA score is measured every day after starting empiric antibiotic treatment. | The first six days after starting empiric antibiotic treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Empiric antibiotic therapy