臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 28, 2026
Last modified on	Jan. 28, 2026
Trial ID	jRCT1030250690

Scientific Title	Clinical Prognosis and Molecular Epidemiology of Bacteremia Caused by Third-Generation Cephalosporin -Resistant (3GCR) Escherichia coli and Klebsiella spp.: An International Multicenter Observational Study (ABLe Study (ARISE ESBL Observational Study))
Public Title	ABLe Study (ABLe Study)

Contact for Scientific Queries	Name	Sho Saito
	Affiliation	Japan Institute for Health Security
	Address	1-21-1, Toyama, Shinjyukuku, 165-8655, Tokyo, Japan
	Telephone	+81-3-3202-7181
	E-mail	a-esbl_info@jihs.go.jp
Contact for Public Queries	Name	Sho Saito
	Affiliation	Japan Institute for Health Security
	Address	1-21-1, Toyama, Shinjyukuku, 165-8655, Tokyo, Japan
	Telephone	+81-3-3202-7181
	E-mail	a-esbl_info@jihs.go.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 17, 2025
Target sample size		3000
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Participants will be enrolled in this study if they meet the following criteria: E. coli or Klebsiella spp. intermediate or resistant to ceftriaxone or cefotaxime is isolated from a blood culture specimen This is defined as a minimum inhibitory concentration (MIC) >= 2 mg/L when using the broth microdilution testing method or a zone of inhibition of <=22 mm (ceftriaxone) or <=25 mm (cefotaxime) when using the disk diffusion testing method (Clinical and Laboratory Standards Institute [CLSI] M100 34th edition).
	Exclusion Criteria	Participants will not be enrolled in this study if any of the following conditions apply: - Polymicrobial growth are detected in the blood culture specimen, - In countries/sites where informed consent is required, consent/assent is not obtained from the participant or Legally Authorized Representative (LAR) - In countries/sites where an opt-out approach is permitted, the participant or LAR explicitly opts out of participation - Patients who are not hospitalized and who do not have a scheduled hospitalization at the time consent is requested
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Bacteremia caused by third-generation cephalosporin-resistant (3GCR) Escherichia coli or Klebsiella
Health Condition(s) Keyword		Bacteremia, Bloodstream infection, Third-generation cephalosporin resistance, Drug-resistant bacteria, Escherichia coli, Klebsiella spp.
Primary Outcome(s)		Mortality
Secondary Outcome(s)		- Length of hospital stay - Treatment practices in participating countries, including antimicrobial agents used and treatment strategies - Antimicrobial susceptibility patterns of the isolated strains, including the genetic basis of resistance mechanisms and regional differences in clinical outcomes and microbiological characteristics

Primary Sponsor	NA

Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and Development (AMED)
Secondary Sponsor

Name of Certified Review Board	Certified Review Board of Japan Institute for Health Security
Address	1-21-1, Toyama, Shinjyukuku, Tokyo, Japan, Tokyo
Telephone	+81-3-3202-7181
E-Mail	rinrijm@jihs.go.jp
Approval Status	Approval
Date of approval	Dec. 17, 2025

Plan to share IPD	Yes
Plan description	For the purpose of analyzing the study test results and their association with clinical outcomes, the following information collected from medical records at the National Center for Global Health and Medicine, Japan Institute for Health Security, will be shared with the Faculty of Medicine, Fujita Health University, a collaborating research institution responsible for genetic testing and analysis of bacterial isolates: Diagnosis; demographic information including age and sex; length of hospital stay; medical history including comorbidities according to the Charlson Comorbidity Index; immunosuppressive status; history of overseas travel within three months prior to specimen collection; vital signs; level of consciousness; severity scores including the qSOFA score; clinical laboratory test results including white blood cell count and C-reactive protein (CRP); antimicrobial agents used; and clinical outcomes including intensive care unit (ICU) stay. The shared data will be assigned a study identification number only, and will not include any direct identifiers such as names, addresses, contact information, or medical record numbers.

Plan to share IPD

Yes

Plan description

For the purpose of analyzing the study test results and their association with clinical outcomes, the following information collected from medical records at the National Center for Global Health and Medicine, Japan Institute for Health Security, will be shared with the Faculty of Medicine, Fujita Health University, a collaborating research institution responsible for genetic testing and analysis of bacterial isolates: Diagnosis; demographic information including age and sex; length of hospital stay; medical history including comorbidities according to the Charlson Comorbidity Index; immunosuppressive status; history of overseas travel within three months prior to specimen collection; vital signs; level of consciousness; severity scores including the qSOFA score; clinical laboratory test results including white blood cell count and C-reactive protein (CRP); antimicrobial agents used; and clinical outcomes including intensive care unit (ICU) stay. The shared data will be assigned a study identification number only, and will not include any direct identifiers such as names, addresses, contact information, or medical record numbers.

Countries of Recruitment（Except Japan）	Indonesia/Malaysia/Philippines/Thailand/Vietnam