Procalcitonin in Diagnosing Bacteremia in the Emergency Department

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2004 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00174122
First received: September 13, 2005
Last updated: February 28, 2006
Last verified: September 2004
  Purpose

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
Sepsis
Fever

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 60
Study Start Date: July 2005
Estimated Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Emergency department patient
  • Patient suspected sepsis

Exclusion Criteria:

  • Patient less than 15 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174122

Contacts
Contact: Shey-Ying Chen, MD 886-2-23123456 ext 2831 cutecsy@ha.mc.ntu.edu.tw

Locations
Taiwan
Department of Emergency Medicine, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Wen-Jone Chen, MD, PhD    886-2-23123456 ext 2831    jone@ha.mc.ntu.edu.tw   
Principal Investigator: Shey-Ying Chen, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Wen-Jone Chen, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00174122     History of Changes
Other Study ID Numbers: 9361701115
Study First Received: September 13, 2005
Last Updated: February 28, 2006
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014