UMIN-ICDS Clinical Trial

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

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

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

Primary outcomes

Our primary outcome is Early antibiotics treatment failure (EATF)

Key secondary outcomes

Our secondary outcome is mortality, change of antibiotics, and operation.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

hiroyoshi-Iwata@cehs.hokudai.ac.jp

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

Email

hiroyoshi-Iwata@cehs.hokudai.ac.jp

Institute

Hokkaido university

Institute

Department

Personal name

Hiroyoshi Iwata

Organization

Hokkaido university

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

Email

hiroyoshi-Iwata@cehs.hokudai.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2023

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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/icdr_e/ctr_view.cgi?recptno=R000057670