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Study of the effect of fluoroquinolones on the risk of aortic disease development using claims database

Causal risk estimation of fluoroquinolones for the occurrence of aortic events using claims database - Risk assessment of fluoroquinolones for the occurrence of aortic events

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000051618
Enrollment
200000
Registered
2023-07-15
Start date
2023-07-18
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

Outpatients receiving oral antibiotic prescription

Interventions

None listed

Sponsors

Shizuoka Graduate University of Public Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Cases registered in the Shizuoka Kokuho Database -Patients who received a prescription for oral fluoroquinolones or oral amoxicillin (+/- clavulanic acid) as an outpatient between April 2013 and July 2020 -Patients aged 50 years or older at the time of oral antibiotic prescription -Patients with a baseline period of 1 year prior to oral antibiotic prescription

Exclusion criteria

Exclusion criteria: -Patients who received a prescription for fluoroquinolones or amoxicillin (+/- clavulanic acid) in the 4 months prior to the start of observation (antibiotic prescription episode) -Patients who were hospitalized in the 12 months prior to the start of observation -Cases with history of aortic aneurysm or aortic dissection up to prescription of oral antibiotic (these cases will be analyzed as an additional analysis) -Cases with Marfan syndrome, vascular type Ehlers-Danlos syndrome, and Lois-Dietz syndrome up to prescription of oral antibiotic -Cases that do not allow for a baseline period of 12 months prior to the start of observation

Design outcomes

Primary

MeasureTime frame
Aortic events (hospitalization due to aortic aneurysm or aortic dissection) from oral antibiotic prescription to 2 months later

Countries

Japan

Contacts

Public ContactChikara Ueki

Shizuoka Graduate University of Public Health Graduate School of Public Health

st.cueki@s-sph.ac.jp+81-54-295-5400

Outcome results

None listed

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