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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
History of Changes
  Purpose

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.


Condition Intervention
Sepsis
Intensive Care
 Other: Procalcitonin measurement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Reduction of Antibiotic Use in the ICU: Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Sepsis
U.S. FDA Resources

Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • duration of antibiotic therapy [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 28 day mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Arms Assigned Interventions
Experimental: PCT guided antibiotic therapy Other: Procalcitonin measurement
Daily procalcitonin measurement. Antibiotic discontinuation policy dependent on procalcitonin value. In the control group standard duration of antibiotic therapy.
Placebo Comparator: Standard antibiotic therapy Other: Procalcitonin measurement
Daily procalcitonin measurement. Antibiotic discontinuation policy dependent on procalcitonin value. In the control group standard duration of antibiotic therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987818

Contacts
Contact: Hendrikus J van Leeuwen, MD PhD +31-88-0058888 ext 6735 hjvanleeuwen@alysis.nl

Locations
Netherlands
Alysis Zorggroep, Rijnstate Hospital Not yet recruiting
Arnhem, Gelderland, Netherlands, 6800TA
Contact: Hendrikus J van Leeuwen, MD PhD     +31-88-0058888 ext 6735     hjvanleeuwen@alysis.nl    
Sub-Investigator: Els Rengers, MD            
Sponsors and Collaborators
Rijnstate Hospital
Stichting Vrienden van het Alysis Leerhuis
  More Information

No publications provided

Responsible Party: HJ van Leeuwen, MD PhD, Alysis Zorggroep, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT00987818     History of Changes
Other Study ID Numbers: 630-190809
Study First Received: September 16, 2009
Last Updated: December 17, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Rijnstate Hospital:
Biomarkers
Antibiotic therapy

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013