Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU

Study Overview
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Brief Summary
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The adequacy of early empiric antimicrobial therapy is an important factor in determining the outcome in patients with severe sepsis. The duration of adequate antibiotic therapy in these patients however is less clear. Duration of antibiotic therapy in patients with sepsis in the ICU based on inflammatory markers has not been extensively studied. Procalcitonin (PCT) is an acute phase protein that has prognostic value in critically ill patients and can be used to monitor disease activity in sepsis and systemic inflammation. This study will examine the effect of PCT guided antibiotic therapy compared with conventional antibiotic therapy on treatment duration in patients with sepsis admitted to the ICU.

Official Title
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Reduction of Antibiotic Use in the ICU: Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU

Conditions
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Sepsis, Intensive Care

Intervention / Treatment
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* Other: Procalcitonin measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to the ICU Age > 18 years Antibiotic therapy for sepsis with a suspected or proven focus of infection Exclusion Criteria: Age < 18 years Pregnancy Infection or presumed infection requiring prolonged antibiotic therapy (osteomyelitis, meningitis, endocarditis, septic arthritis, mediastinitis, tuberculosis, Pneumocystis jiroveci pneumonia, Toxoplasmosis, Legionellosis, Listeriosis) Indication for prolonged systemic prophylactic antibiotic therapy Severe viral or parasitic infections (hemorrhagic fever, malaria) Antibiotic therapy started 48 hours before enrollment Severe immunocompromised patients (AIDS with a CD4 count < 200cells/mm3, severe neutropenia(<500 neutrophils/mm3), patients undergoing immunosuppressive therapy after solid organ transplantation) Patients foregoing life sustaining treatment

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCT guided antibiotic therapy<br> | Other: Procalcitonin measurement<br>* Daily procalcitonin measurement. Antibiotic discontinuation policy dependent on procalcitonin value. In the control group standard duration of antibiotic therapy.<br>|
| Placebo Comparator: Standard antibiotic therapy<br> | Other: Procalcitonin measurement<br>* Daily procalcitonin measurement. Antibiotic discontinuation policy dependent on procalcitonin value. In the control group standard duration of antibiotic therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of antibiotic therapy |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day mortality |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers, Antibiotic therapy