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.
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
- 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
- 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
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:
- To clarify the sensitivity and specificity of the serum procalcitonin quantitative test as a clinical indicator of sepsis;
- To identify the cut-off value of the serum procalcitonin level in sepsis screening among various groups of patients with different co-morbidities;
- 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;
- 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.
- 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.
- First posted15 Sep 2005 (estimated)
- Study startJul 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wen-Jone Chen, MD, PhD, Study director, National Taiwan University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin in Diagnosing Bacteremia in the Emergency Department
- ClinicalTrials.gov ID
- NCT00174122
- Acronym / sponsor ID
- 9361701115
- Keywords
- Emergency department, Blood culture, Antimicrobial therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Jun 2006
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To clarify the sensitivity and specificity of the serum procalcitonin quantitative test as a clinical indicator of sepsis;
- To identify the cut-off value of the serum procalcitonin level in sepsis screening among various groups of patients with different co-morbidities;
- 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;
- 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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Emergency department patient
- Patient suspected sepsis
Key exclusion criteria (1 listed)
- Patient less than 15 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Jone Chen, MD, PhD study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
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.