UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000034797
Receipt No. R000039686
Scientific Title The diagnostic accuracy of biomarkers for the prediction of sepsis and bacteremia in patients with suspected infection: a prospective observational study
Date of disclosure of the study information 2018/11/12
Last modified on 2020/01/08 (Ver. 4)

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Basic information
Public title The diagnostic accuracy of biomarkers for the prediction of sepsis and bacteremia in patients with suspected infection: a prospective observational study
Acronym Early diagnosis of sepsis and bacteremia
Scientific Title The diagnostic accuracy of biomarkers for the prediction of sepsis and bacteremia in patients with suspected infection: a prospective observational study
Scientific Title:Acronym Early diagnosis of sepsis and bacteremia
Region
Japan

Condition
Condition Suspected infectious disease
Classification by specialty
Medicine in general Infectious disease
Classification by malignancy Others
Genomic information NO

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

Assessment
Primary outcomes Result of blood culture
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 had been hospitalized at the Kawasaki Medical School Hospital Advanced Critical Care Center and who had undergone blood culture collection due to suspected infectious disease upon admission or during hospitalization.
Key exclusion criteria Only patients who had undergone follow-up blood culture to confirm blood culture negativity were excluded.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Shiino
Middle name
Last name Yasukazu
Organization Kawasaki Medical School
Division name Department of Acute Medicine
Zip code 7010192
Address 577, Matsushima, Kurashiki-shi, Okayama, 701-0192, JAPAN
TEL 086-462-1111
Email shiino@me.com

Public contact
Name of contact person
1st name Yasukazu
Middle name
Last name Shiino
Organization Kawasaki Medical School
Division name Department of Acute Medicine
Zip code 7010192
Address 577, Matsushima, Kurashiki-shi, Okayama, 701-0192, JAPAN
TEL 086-462-1111
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 Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kawasaki Medical School
Address 577, Matsushima, Kurashiki-shi, Okayama, 701-0192, JAPAN
Tel 086-464-1076
Email kmsrec@med.kawasaki-m.ac.jp

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 12 Day

Related information
URL releasing protocol https://m.kawasaki-m.ac.jp/kenkyu/rinri/document/kadai/2018/1926-2.pdf
Publication of results Published

Result
URL related to results and publications http://igakkai.kms-igakkai.com/wp/wp-content/uploads/2019en/KMJ-E201945027.pdf
Number of participants that the trial has enrolled 210
Results 
Presepsis and Procalcitonin demonstrated good predictive ability for bacteremia in patients suspected of infection. Using the cut-off values determined in our analysis, we achieved a clinically useful NPV. PSEP and PCT may be useful for ruling out bacteremia.
Results date posted
2020 Year 01 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Our study comprised patients who had been hospitalized in the Advanced Critical Care Center at Kawasaki Medical School Hospital in Okayama, Japan, from December 2014 through September 2016 and had been performed blood cultures due to suspected bacteremia upon admission or during hospitalization. Only patients who had a negative follow-up blood culture were excluded.
Participant flow 
Observational study
Adverse events 
none
Outcome measures 
Blood culture result, Preseason, Procalcitonin, CRP, Blood test, Vital signs.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 09 Month 08 Day
Date of IRB
2014 Year 09 Month 08 Day
Anticipated trial start date
2014 Year 12 Month 01 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2018 Year 04 Month 30 Day
Date trial data considered complete
2018 Year 06 Month 30 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information Basic information of each patients(Age, Gender, comorbidity), vital signs, result of routine blood test, Presepsin , Procalcitonin, result of blood culture, result of Real-time PCR of blood, suspected site of infection, qSOFA in ER.

Management information
Registered date
2018 Year 11 Month 07 Day
Last modified on
2020 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039686