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SepsisNCT00174122

Procalcitonin in Diagnosing Bacteremia in the Emergency Department

An observational study of Sepsis and Fever, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Sepsis, Fever
How many people
60 participants
Where
1 siteTaiwan
Study dates
Jul 2005to Jun 2006
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Emergency department patient
  • Patient suspected sepsis

Who cannot join

  • Patient less than 15 years of age

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • Department of Emergency Medicine, National Taiwan University Hospital

    Taipei, 100

    Wen-Jone Chen, MD, PhD, 886-2-23123456 ext. 2831, jone@ha.mc.ntu.edu.tw

    Shey-Ying Chen, MD

    Recruiting

Other trials in Taiwan

About this study

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.

Read more

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.

Conditions
Sepsis, Fever
Keywords
Emergency department, Blood culture, Antimicrobial therapy
Medical subject headings
Sepsis, Fever, Emergencies

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startJul 2005
  3. Study completionJun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Defined population
Time perspective
Other
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00174122
Sponsor's protocol ID
9361701115
Status last verified
Sep 2004
First submitted
13 Sep 2005
Last updated
1 Mar 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Fever, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shey-Ying Chen, MD (886-2-23123456 ext. 2831, cutecsy@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2006.

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