Procalcitonin in Diagnosing Bacteremia in the Emergency Department

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. Identifier: NCT00174122
Recruitment Status : Unknown
Verified September 2004 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : March 1, 2006
Information provided by:
National Taiwan University Hospital

Brief Summary:

Nowadays, a physician plays a more important role in managing patients with potential infectious complications in the emergency room. Previous studies demonstrated the importance of early and adequate anti-microbial therapy in reducing the mortality and morbidity of patients with severe sepsis. However, in one study, about 6% of clinically significant bacteremic patients were misdiagnosed and discharged from the emergency room. In other studies, about 8.5 to approximately 17% of empirical antibiotic selection was judged inappropriately according to subsequent microbiology, and anti-microbial susceptibility was a result. It reflects the diversity in the presentations of infectious diseases and limited available microbiological reports from the first-line emergency physicians. Timely diagnosis and selection of appropriate antibiotics/treatment in treating those patients challenge an emergency physician more than ever before.

A serum marker, procalcitonin, was recently demonstrated to be a potential indicator in distinguishing between non-infectious and infectious acute inflammatory reactions, viral and bacterial infections, and non-bacteremic and bacteremic infections. It also demonstrates the association with high-mortality risk in patients with severe sepsis. However, some areas remain inconclusive in the clinical application of this potential serum marker.

The investigators designed this prospective study with the following purposes:

  1. To clarify the sensitivity and specificity of the serum procalcitonin quantitative test as a clinical indicator of sepsis;
  2. To identify the cut-off value of the serum procalcitonin level in sepsis screening among various groups of patients with different co-morbidities;
  3. To test the potential role of the procalcitonin quantitative test in identifying occult sepsis in patients with an acute undifferentiated febrile reaction in the emergency room;
  4. To test the possibility of the sequential procalcitonin quantitative test as a serological guide of the appropriateness of an empirical antibiotic before the microbiology results are available.

Conclusions in the investigators' study will clarify the clinical application of the serum procalcitonin quantitative test in the differential diagnosis of patients with systemic inflammatory reaction syndrome, the screening of high-risk sepsis patients, and the effectiveness of an empirical antibiotic evaluation.

Condition or disease
Sepsis Fever

Study Type : Observational
Enrollment : 60 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Study Start Date : July 2005
Study Completion Date : June 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Emergency department patient
  • Patient suspected sepsis

Exclusion Criteria:

  • Patient less than 15 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00174122

Contact: Shey-Ying Chen, MD 886-2-23123456 ext 2831

Department of Emergency Medicine, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Wen-Jone Chen, MD, PhD    886-2-23123456 ext 2831   
Principal Investigator: Shey-Ying Chen, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Study Director: Wen-Jone Chen, MD, PhD National Taiwan University Hospital Identifier: NCT00174122     History of Changes
Other Study ID Numbers: 9361701115
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 1, 2006
Last Verified: September 2004

Keywords provided by National Taiwan University Hospital:
Emergency department
Blood culture
Antimicrobial therapy