UMIN-ICDS Clinical Trial

Public title

A study on the association between early antibiotic use and hospitalization within two weeks in O157/EHEC infection

Acronym

JMDC O157 Antibiotic-Hospitalization Study

Scientific Title

Association between initial antibiotic prescription and 14-day hospitalization risk in infectious enteritis episodes leading to O157/EHEC diagnosis: a target trial emulation study using the JMDC Claims Database and JMDC Latter-Stage Elderly data

Scientific Title:Acronym

O157/EHEC Antibiotic TTE Study (JMDC)

Region

Japan

Condition

Infectious enteritis episodes leading to a diagnosis of enterohemorrhagic Escherichia coli (O157/EHEC) infection

Classification by specialty

Gastroenterology

Infectious disease

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Using the JMDC Claims Database and JMDC Latter-Stage Elderly data, to evaluate, within a target trial emulation framework, whether systemic antibiotic prescription on the episode start date (time zero) is associated with 14-day all-cause hospitalization risk, compared with no prescription on the same day, among infectious enteritis episodes leading to O157/EHEC diagnosis.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

All-cause hospitalization within 14 days after time zero (the start date of the infectious enteritis episode). Risk ratio (95% CI) estimated in the propensity-score overlap-weighted population.

Key secondary outcomes

(1) Newly recorded hemolytic uremic syndrome (HUS; ICD-10 D59.3) within 30 days after time zero. (2) 14-day hospitalization risk by antibiotic class (fluoroquinolones, cephalosporins, macrolides, fosfomycin, others, multiple). Pre-specified age-stratified analysis (0-17, 18-64, 65-74, >=75 years).

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) A recorded O157/EHEC diagnosis (ICD-10 A04.3; suspected diagnoses excluded). (2) Time zero = the first visit date of an infectious-enteritis-related diagnosis recorded 0-14 days before the first O157/EHEC diagnosis, or the first O157/EHEC diagnosis date if none. (3) Continuous enrollment for >=6 months before time zero. All ages.

Key exclusion criteria

(1) No continuous 6-month enrollment before time zero. (2) Only a suspected O157/EHEC diagnosis. (3) Missing age, sex, or enrollment information. (4) Hospitalized on time zero or already hospitalized at time zero (to avoid unclear temporality/reverse causation).

Target sample size

3000

Name of lead principal investigator

1st name	Satoshi
Middle name
Last name	Kutsuna

Organization

The University of Osaka, Graduate School of Medicine Faculty of Medicine

Division name

Department of Infection Prevention and Control

Zip code

565-0871

Address

2-2, Yamadaoka, Suita city

TEL

0836-6879-5111

Email

kutsuna@hp-infect.med.osaka-u.ac.jp

Name of contact person

1st name	Satoshi
Middle name
Last name	Kutsuna

Organization

The University of Osaka, Graduate School of Medicine Faculty of Medicine

Division name

Department of Infection Prevention and Control

Zip code

565-0871

Address

2-2, Yamadaoka, Suita city

TEL

0836-6879-5111

Homepage URL

Email

kutsuna@hp-infect.med.osaka-u.ac.jp

Institute

The University of Osaka

Institute

Department

Personal name

Organization

The University of Osaka

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

None

Name of secondary funder(s)

None

Organization

The University of Osaka Hospital, Ethical Review Board

Address

2-15, Yamadaoka, Suita city

Tel

0836-6879-5111

Email

rinri@hp-crc.med.osaka-u.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

大阪大学大学院医学系研究科 感染制御学 / The University of Osaka, Graduate School of Medicine

Date of disclosure of the study information

2026

Year

06

Month

11

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

Preinitiation

Date of protocol fixation

2026

Year

04

Month

14

Day

Date of IRB

2026

Year

04

Month

14

Day

Anticipated trial start date

2026

Year

06

Month

11

Day

Last follow-up date

2026

Year

06

Month

11

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a retrospective cohort (target trial emulation) study using the anonymized JMDC Claims Database and JMDC Latter-Stage Elderly medical data. The association between antibiotic prescription and 14-day hospitalization risk is estimated in a propensity-score overlap-weighted population.

Registered date

2026

Year

06

Month

11

Day

Last modified on

2026

Year

06

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070799