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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

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.

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Detailed Description

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Conditions

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Sepsis Intensive Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PCT guided antibiotic therapy

Group Type EXPERIMENTAL

Procalcitonin measurement

Intervention Type OTHER

Daily procalcitonin measurement. Antibiotic discontinuation policy dependent on procalcitonin value. In the control group standard duration of antibiotic therapy.

Standard antibiotic therapy

Group Type PLACEBO_COMPARATOR

Procalcitonin measurement

Intervention Type OTHER

Daily procalcitonin measurement. Antibiotic discontinuation policy dependent on procalcitonin value. In the control group standard duration of antibiotic therapy.

Interventions

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Procalcitonin measurement

Daily procalcitonin measurement. Antibiotic discontinuation policy dependent on procalcitonin value. In the control group standard duration of antibiotic therapy.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No