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

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 - O157/EHEC Antibiotic TTE Study (JMDC)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000061873
Enrollment
3000
Registered
2026-06-11
Start date
2026-06-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Sponsors

The University of Osaka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
(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).

Countries

Japan

Contacts

Public ContactSatoshi Kutsuna

The University of Osaka, Graduate School of Medicine Faculty of Medicine Department of Infection Prevention and Control

kutsuna@hp-infect.med.osaka-u.ac.jp0836-6879-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026