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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034755
Receipt No. R000039634
Official scientific title of the study Diagnostic accuracy of biomarkers and Real-time PCR for early diagnosis of bacteremia.
Date of disclosure of the study information 2018/11/05
Last modified on 2018/11/02

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Basic information
Official scientific title of the study Diagnostic accuracy of biomarkers and Real-time PCR for early diagnosis of bacteremia.
Title of the study (Brief title) Early diagnosis of sepsis and bacteremia.
Region
Japan

Condition
Condition Suspected bacteremia
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the diagnostic accuracy of biomarkers for prediction of bacteremia in patients with suspected infectious diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood culture positive or negative
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who undergone blood culture are considered as patients suspected of having an infection and are included in this single-facility, prospective, observational study.
Key exclusion criteria Only patients who undergo follow-up blood culture to confirm blood culture negativity are excluded.
Target sample size 300

Research contact person
Name of lead principal investigator Yasukazu Shiino
Organization Kawasaki Medical School
Division name Department of Acute Medicine
Address 577, Matsushima, Kurashiki-shi, Okayama, 701-0192, JAPAN
TEL +81-86-462-1111
Email shiino@me.com

Public contact
Name of contact person Yasukazu Shiino
Organization Kawasaki Medical School
Division name Department of Acute Medicine
Address 577, Matsushima, Kurashiki-shi, Okayama, 701-0192, JAPAN
TEL +81-86-462-1111
Homepage URL
Email shiino@me.com

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 05 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2014 Year 09 Month 08 Day
Anticipated trial start date
2014 Year 12 Month 02 Day
Last follow-up date
Date of closure to data entry
2016 Year 09 Month 07 Day
Date trial data considered complete
2018 Year 06 Month 01 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information In addition to general blood collection, PSEP and procalcitonin (PCT) were measured simultaneously with the blood culture collection. We retrospectively confirmed qSOFA scores that had been recorded within the study period for patients who had undergone blood culture testing as part of their emergency outpatient treatment.

Management information
Registered date
2018 Year 11 Month 02 Day
Last modified on
2018 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039634

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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