UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Epidemiological study of bacterial pneumonia in Izumo.
Title of the study (Brief title)	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	Takeshi Isobe
Organization	Shimane University
Division name	Department of Internal Medicine, Division of Clinical Oncoloogy and Respiratory Medicine
Address	89-1 Enyacho, Izumo, Shimane, Japan
TEL
Email

Public contact
Name of contact person	Maki Tsubokura
Organization	Shimane University
Division name	Department of Internal Medicine, Division of Clinical Oncoloogy and Respiratory Medicine
Address	89-1 Enyacho, Izumo, Shimane, Japan
TEL	0853-20-2580
Homepage URL
Email

Sponsor
Institute	Japan Association of Health Service
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013028