UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044753 |
|---|---|
| Receipt number | R000049449 |
| Scientific Title | Proton-pump inhibitor use and risk of gut-origin bloodstream infection: a hospital-based case-control study |
| Date of disclosure of the study information | 2021/07/05 |
| Last modified on | 2023/01/04 12:26:41 |
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Basic information
Public title
Proton-pump inhibitor use and risk of gut-origin bloodstream infection: a hospital-based case-control study
Acronym
PPI use and risk of gut-origin BSI: a hospital-based case-control study
Scientific Title
Proton-pump inhibitor use and risk of gut-origin bloodstream infection: a hospital-based case-control study
Scientific Title:Acronym
PPI use and risk of gut-origin BSI: a hospital-based case-control study
Region
| Japan |
Condition
Condition
gut-origin bloodstream infection
Classification by specialty
| Gastroenterology | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate if patients under proton-pump inhibitor (PPI) therapy have higher risk of developing gut-origin bloodstream infection
Basic objectives2
Others
Basic objectives -Others
To explore potential factors that affect the link between PPI and gut-origin BSI
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Odds ratio of gut-origin bloodstream infection among PPI users and non-users as well as its 95% confidence interval adjusted for confounding factors
Key secondary outcomes
In a sensitivity analysis that excluded individuals who did not have sufficient examination to find infectious focus, we calculated odds ratio of gut-origin bloodstream infection among PPI users and non-users as well as its 95% confidence interval adjusted for confounding factors.
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients aged 20 years and older who had inpatient treatment for bloodstream infection with 2 sets of positive blood culture in Ichinomiya-Nishi hospital in 2019
Key exclusion criteria
Patients under 20 years old were excluded.
Patients who disagreed with enrollment of the study under the opt-out model were excluded.
When patients had two or more episodes of bloodstream infections, only the first episode was included in the study.
Target sample size
309
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Hayashi |
Organization
Ichinomiya-Nishi Hospital
Division name
Department of gastroenterology
Zip code
4940001
Address
Hira 1, Kaimei, Ichinomiya, Aichi, JAPAN
TEL
0586480077
sntr.hayashi@gmail.com
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Hayashi |
Organization
Ichinomiya-Nishi Hospital
Division name
Department of gastroenterology
Zip code
4940001
Address
Hira 1, Kaimei, Ichinomiya, Aichi, JAPAN
TEL
0586480077
Homepage URL
sntr.hayashi@gmail.com
Sponsor or person
Institute
Ichinomiya-Nishi Hospital
Department of gastroenterology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ichinomiya-Nishi Hospital
Address
Hira 1, Kaimei, Ichinomiya, Aichi, JAPAN
Tel
0586480077
sntr.hayashi@gmail.com
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
| 2021 | Year | 07 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
309
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
This study is still under analysis and modification of the results.
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
| 2021 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study (a hospital-based case-control study).
Management information
Registered date
| 2021 | Year | 07 | Month | 04 | Day |
Last modified on
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049449
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/07/19 | BT 臨床研究計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/07/19 | Data template.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/07/19 | Data final.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/49449
