UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011119 |
|---|---|
| Receipt number | R000013028 |
| Scientific Title | Epidemiological study of bacterial pneumonia in Izumo. |
| Date of disclosure of the study information | 2013/07/05 |
| Last modified on | 2017/01/06 11:16:31 |
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Basic information
Public title
Epidemiological study of bacterial pneumonia in Izumo.
Acronym
Epidemiological study of bacterial pneumonia in Izumo.
Scientific Title
Epidemiological study of bacterial pneumonia in Izumo.
Scientific Title:Acronym
Epidemiological study of bacterial pneumonia in Izumo.
Region
| Japan |
Condition
Condition
Pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of bacterial pneumonia and pneumococcal pneumonia among aged patients of 65 yrs and older with pneumonia, the severity, the mortality, hospitalization days and the vaccination rate.
To investigate changes in the vaccination rate and the severity between pre- and post- periods of the public funding for the pneumococcal vaccination in Izumo city Shimane.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of bacterial pneumonia and pneumococcal pneumonia among pneumonia patients
Key secondary outcomes
1)The severity of bacterial pneumonia and pneumococcal pneumonia
2) Hospitalization days and out patient visits of bacterial pneumonia and pneumococcal patients
3) mortality of bacterial pneumonia and pneumococcal pneumonia
Base
Study type
Others,meta-analysis etc
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients of 65 years old and over who were diagnosed as pneumonia at the study institutions
Key exclusion criteria
None
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Isobe |
Organization
Shimane University
Division name
Department of Internal Medicine, Division of Clinical Oncoloogy and Respiratory Medicine
Zip code
Address
89-1 Enyacho, Izumo, Shimane, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maki Tsubokura |
Organization
Shimane University
Division name
Department of Internal Medicine, Division of Clinical Oncoloogy and Respiratory Medicine
Zip code
Address
89-1 Enyacho, Izumo, Shimane, Japan
TEL
0853-20-2580
Homepage URL
Sponsor or person
Institute
Japan Association of Health Service
Institute
Department
Personal name
Funding Source
Organization
Japan Association of Health Service
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | 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
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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1st/2nd Period:Retrospective epidemiological joint research conducted at multiple facilities
3rd/4th Period:Prospective epidemiological joint research conducted at multiple facilities
Management information
Registered date
| 2013 | Year | 07 | Month | 04 | Day |
Last modified on
| 2017 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013028
