Tokyo, June 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061873) titled 'A study on the association between early antibiotic use and hospitalization within two weeks in O157/EHEC infection' on June 11.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka

Condition: Condition - Infectious enteritis episodes leading to a diagnosis of enterohemorrhagic Escherichia coli (O157/EHEC) infection Classification by malignancy - Others Genomic information - NO

Objective: 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

Eligibility: 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 Size - 3000

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070799

Disclaimer: Curated by HT Syndication.