Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062449) titled 'A study of whether prescribing an antibiotic at the first outpatient visit for common uncomplicated acute respiratory tract infection (common cold, acute upper respiratory infection, or acute bronchitis) reduces pneumonia or respiratory-infection-related hospitalization within 14 days, using a large health insurance claims database' on Aug. 3.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka, Graduate School of Medicine Faculty of Medicine

Condition: Condition - Uncomplicated acute respiratory tract infection (common cold, acute upper respiratory infection, or acute bronchitis); the outcome is pneumonia or respiratory-infection-related hospitalization. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Using the JMDC Claims Database, to estimate whether prescribing a systemic antibiotic (WHO-ATC J01) at the index outpatient visit (time zero) for common cold, acute upper respiratory infection, or acute bronchitis, compared with no prescription, is associated with the 14-day risk of pneumonia or respiratory-infection-related hospitalization, within a target trial emulation framework. The average treatment effect in the overlap population (risk ratio and risk difference) is estimated using propensity-score overlap weighting. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - First-per-patient outpatient episodes of common cold (ICD-10 J00), acute upper respiratory infection (J06.x), or acute bronchitis (J20.x) in the JMDC Claims Database (employment-based and late-elderly enrollees; data observation period 2005-2025; suspected diagnoses excluded). Eligibility requires at least 6 months of prior enrollment, no qualifying respiratory diagnosis, systemic antibiotic, or severe respiratory outcome in the preceding 30 days (antibiotic/respiratory washout), and no pneumonia, other same-day antibiotic-indication infection, or respiratory hospitalization on or within 3 days around time zero. One first episode per person is analysed. All ages. Key exclusion criteria - Episodes with suspected diagnoses. Less than 6 months of continuous enrollment before time zero. A qualifying respiratory diagnosis, systemic antibiotic, or severe respiratory outcome within the 30 days before time zero. Pneumonia, another same-day antibiotic-indication infection, or respiratory hospitalization on or within 3 days around time zero. Target Size - 12233602

Recruitment Status: Recruitment status - Completed 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 04 Month 14 Day Last follow-up date - 2026 Year 08 Month 03 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071474

Disclaimer: Curated by HT Syndication.