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

This study has been withdrawn prior to enrollment.
(No MEC approval)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00987818
First Posted: October 1, 2009
Last Update Posted: September 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stichting Vrienden van het Alysis Leerhuis
Information provided by:
Rijnstate Hospital
September 16, 2009
October 1, 2009
September 2, 2015
Not Provided
Not Provided
duration of antibiotic therapy [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT00987818 on ClinicalTrials.gov Archive Site
28 day mortality [ Time Frame: 28 days ]
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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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.
 
Withdrawn
0
Not Provided
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00987818
630-190809
No
Not Provided
Not Provided
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