UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051618 |
|---|---|
| Receipt number | R000058887 |
| Scientific Title | Causal risk estimation of fluoroquinolones for the occurrence of aortic events using claims database |
| Date of disclosure of the study information | 2023/07/15 |
| Last modified on | 2024/01/14 23:14:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of the effect of fluoroquinolones on the risk of aortic disease development using claims database
Acronym
Risk assessment of fluoroquinolones for aortic disease development
Scientific Title
Causal risk estimation of fluoroquinolones for the occurrence of aortic events using claims database
Scientific Title:Acronym
Risk assessment of fluoroquinolones for the occurrence of aortic events
Region
| Japan |
Condition
Condition
Outpatients receiving oral antibiotic prescription
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether use of fluoroquinolones is a risk for aortic events
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Aortic events (hospitalization due to aortic aneurysm or aortic dissection) from oral antibiotic prescription to 2 months later
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
200000
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Nakatani |
Organization
Shizuoka Graduate University of Public Health
Division name
Graduate School of Public Health
Zip code
420-0881
Address
4-27-2 Kita Ando, Aoi-ku, Shizuoka City, Shizuoka, Japan
TEL
+81-54-295-5400
nakatani.eiji.int@gmail.com
Public contact
Name of contact person
| 1st name | Chikara |
| Middle name | |
| Last name | Ueki |
Organization
Shizuoka Graduate University of Public Health
Division name
Graduate School of Public Health
Zip code
420-0881
Address
4-27-2 Kita Ando, Aoi-ku, Shizuoka City, Shizuoka, Japan
TEL
+81-54-295-5400
Homepage URL
st.cueki@s-sph.ac.jp
Sponsor or person
Institute
Shizuoka Graduate University of Public Health
Institute
Department
Personal name
Funding Source
Organization
Shizuoka prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Shizuoka Graduate University of Public Health
Address
4-27-2 Kita Ando, Aoi-ku, Shizuoka City, Shizuoka, 420-0881, Japan
Tel
+81-54-295-5400
kenkyu@s-sph.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
155126
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
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 19 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 19 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 09 | Day |
Other
Other related information
A propensity score-matched comparative study will be conducted using the Shizuoka Kokuho Database (SKDB) to confirm the increased risk of aortic events with fluoroquinolone use.
1) Target Patients: The fluoroquinolone group and the amoxicillin +/- clavulanic acid group will be identified based on prescription data in the SKDB.
-Inclusion criteria.
Cases registered in the Shizuoka Kokuho Database.
Patients who received a prescription for oral fluoroquinolones or oral amoxicillin (+/- clavulanic acid).
Patients aged 50 years or older at the time of the oral antibiotic prescription.
Patients with a baseline period of 1 year prior to the oral antibiotic prescription.
-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 a history of aortic aneurysm or aortic dissection up to the oral antibiotic prescription (these cases will be analyzed as an additional analysis).
Cases with a history of Marfan syndrome, Loeys-Dietz Syndrome or Vascular Ehlers-Danlos Syndrome.
Cases that do not allow a baseline period of 12 months before the start of observation.
2) Outcome definition: The primary outcome is aortic event (hospitalization for aortic aneurysm or aortic dissection) up to 2 months after oral antibiotic prescription.
3) Statistical analysis: Fluoroquinolone-treated patients will be matched 1:1 with patients receiving amoxicillin (+/- clavulanic acid) based on propensity scores estimated using a logistic regression model including confounders such as age, sex, comorbidities, and prescription drugs. The balance of covariates in the matched cohort is assessed by testing for standardized differences between groups. Risk difference for aortic events with fluoroquinolone use compared to amoxicillin (+/- clavulanic acid) will be calculated.
Management information
Registered date
| 2023 | Year | 07 | Month | 15 | Day |
Last modified on
| 2024 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058887
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
