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Clinical Trials/NCT00987818
NCT00987818
Withdrawn
Not Applicable

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

Rijnstate Hospital1 site in 1 countryOctober 1, 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
Rijnstate Hospital
Locations
1
Primary Endpoint
duration of antibiotic therapy
Status
Withdrawn
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2009
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Rijnstate Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

duration of antibiotic therapy

Time Frame: 28 days

Secondary Outcomes

  • 28 day mortality(28 days)

Study Sites (1)

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