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

This study is not yet open for participant recruitment.
Verified December 2012 by Rijnstate Hospital
Sponsor:
Collaborator:
Stichting Vrienden van het Alysis Leerhuis
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00987818
First received: September 16, 2009
Last updated: December 17, 2012
Last verified: December 2012

September 16, 2009
December 17, 2012
Not Provided
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duration of antibiotic therapy [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00987818 on ClinicalTrials.gov Archive Site
28 day mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU
Reduction of Antibiotic Use in the ICU: Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Sepsis
  • Intensive Care
Other: Procalcitonin measurement
Daily procalcitonin measurement. Antibiotic discontinuation policy dependent on procalcitonin value. In the control group standard duration of antibiotic therapy.
  • Experimental: PCT guided antibiotic therapy
    Intervention: Other: Procalcitonin measurement
  • Placebo Comparator: Standard antibiotic therapy
    Intervention: Other: Procalcitonin measurement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
Not Provided
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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
Both
18 Years and older
No
Contact: Hendrikus J van Leeuwen, MD PhD +31-88-0058888 ext 6735 hjvanleeuwen@alysis.nl
Netherlands
 
NCT00987818
630-190809
No
HJ van Leeuwen, MD PhD, Alysis Zorggroep, Rijnstate Hospital
Rijnstate Hospital
Stichting Vrienden van het Alysis Leerhuis
Not Provided
Rijnstate Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP