UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050664 |
|---|---|
| Receipt number | R000057670 |
| Scientific Title | Japan Bacteremia Inpatient Cohort Association |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/06/07 15:10:27 |
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Basic information
Public title
Japan Bacteremia Inpatient Cohort Association (JA-BICA)
Acronym
Bacteremia cohort
Scientific Title
Japan Bacteremia Inpatient Cohort Association
Scientific Title:Acronym
JA-BICA
Region
| Japan |
Condition
Condition
Bacteremia patient who needed admission
Classification by specialty
| Medicine in general | Infectious disease | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study explores risk factors that affect the prognosis of bacteremia, specifically risk assessment and clinical prediction model development with early antibiotics treatment failure (EATF) as an outcome.
Basic objectives2
Others
Basic objectives -Others
Because EATF is a developing outcome, we first conduct a scoping review on EATF.
Given the cohort's strengths, we plan to conduct various themes of bacteremia using the J-BICC data.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Our primary outcome is Early antibiotics treatment failure (EATF)
Key secondary outcomes
Our secondary outcome is mortality, change of antibiotics, and operation.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We recruited the patients as below.
(i) Cases admitted with bacteremia in the period 1 January 2018 to 31 March 2022 in the research hospitals. Cases should be consecutively enrolled.
(ii) 20 years of age or older.
Bacteremia is defined as patients with a positive blood culture, excluding false-positive cases (contamination).
Key exclusion criteria
We excluded the patients as below.
(i) Patient with bacteremia was treated surgically at the time of initial presentation or transferred to the research hospital
(ii) Patient presenting with bacteremia during hospitalization (at least 48 hours after admission).
(iii) Patient not admitted to the research hospital
(iv) Patient less than 20-year-old
(v) Recurrent bacteremia patient during the study period
*Excluded if the patient or his/her representative requests refusal to participate.
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Iwata |
Organization
Hokkaido university
Division name
Center for Environmental and Health Sciences
Zip code
903-0125
Address
Kita 12, Nishi 7. Kita-ku, Sapporo,Hokkaido, Japan
TEL
+81-11-706-4746
hiroyoshi-Iwata@cehs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Iwata |
Organization
Hokkaido university
Division name
Center for Environmental and Health Sciences
Zip code
060-0812
Address
Kita 12, Nishi 7. Kita-ku, Sapporo,Hokkaido, Japan
TEL
+81-11-706-4746
Homepage URL
hiroyoshi-Iwata@cehs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university
Institute
Department
Personal name
Hiroyoshi Iwata
Funding Source
Organization
Hokkaido university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of the Center for Environmental and Health Sciences, Hokkaido university
Address
Kita 12, Nishi 7. Kita-ku, Sapporo,Hokkaido, Japan
Tel
+81-11-706-4746
hiroyoshi-Iwata@cehs.hokudai.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
Collaborative Research Hospitals:
Sapporo Hokushin Hospital (Hokkaido)
Ohara General Hospital (Fukushima)
Kashima Saiseikai Hospital (Ibaraki)
Tokyo Takanawa Hospital (Tokyo)
Yokohama Hodogaya Hospital (Kanagawa)
Seirei Hamamatsu Hospital (Shizuoka)
Rakuaikai Otowa Hospital (Kyoto)
Tottori Prefectural Central Hospital (Tottori)
Ehime Prefectural Central Hospital (Ehime)
Nagasaki Medical Center (Nagasaki)
Academic Support institutions:
Hokkaido University
Yokohama City University
Jikei University School of Medicine
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Aim: This study aims to create a national multicentre cohort on bacteremia and conduct a multifaceted study. We investigated the development of a predictive model of risk factors as indicators of failure of this early antimicrobial treatment. The present study is a multicentre retrospective study involving over ten community hospitals and three universities in Japan. The research participants were hospitalized patients with bacteremia between 1 Jan 2018 and 31 Mar 2022. Ethics: This study followed the Declaration of Helsinki and the Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects in Japan. The principal investigator and co-investigators have no conflicts of interest.
The study was approved by the Ethics Committee of the University of Ryukyus, to which the principal investigator, Hiroyoshi Iwata, belonged, on 1 July 2022. After the principal investigator moved to Hokkaido University, the ethics committee of the Center for Environmental and Health Sciences at Hokkaido University reviewed and approved the study on 17 January 2023.
Management information
Registered date
| 2023 | Year | 03 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057670
