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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004353
Receipt No. R000005195
Scientific Title A prospective epidemiological study for patients with pneumonia in a single center in Japan
Date of disclosure of the study information 2010/10/10
Last modified on 2010/10/07

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Basic information
Public title A prospective epidemiological study for patients with pneumonia in a single center in Japan
Acronym Epidemiological study for patients with pneumonia
Scientific Title A prospective epidemiological study for patients with pneumonia in a single center in Japan
Scientific Title:Acronym Epidemiological study for patients with pneumonia
Region
Japan

Condition
Condition community-acquired pneumonia(CAP),nursing & healthcare-associated pneumonia(NHCAP),hospital-acquired pneumonia(HAP),ventilator-associated pneumonia(VAP)
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate clinical features in patients with CAP,NHCAP,HAP and VAP.
To compare epidemiological data about pneumonia in Japan with those in foreign countries.
Basic objectives2 Others
Basic objectives -Others To analyze backgrounds,causative organisms,severity,roentogenological findings,clinical findings,antimicrobials,outcome and medical costs in each pneumonia category(CAP,NHCAP,HAP,VAP).
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1)Mortality in 30 days
2)Mortality in hospital
3)Pathogens and drug sensitivities
4)Early and late treatment failure
5)Frequencies of antimicrobials
6)Usefullness of parameters
7)Differences between the sexes
8)Medical costs
Key secondary outcomes 1)Verification of adequacy of Japanese guidelines
2)Comparison with foreign reports

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients presenting with new infiltrative shadows on chest X-ray, and symptoms of acute respiratory infection, such as cough,fever,expectoration of purulent sputum,dyspnea and chest pain.
Key exclusion criteria Patients with chest X-ray abnormalities due to other obvious causes.

Patients who do not agree with the enrollment to this study.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Ishida
Organization Kurashiki Central Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 1-1-1,Miwa,Kurashiki,Okayama,Japan
TEL 086-422-0210
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tadashi Ishida
Organization Kurashiki Central Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 1-1-1,Miwa,Kurashiki,Okayama,Japan
TEL 086-422-0210
Homepage URL
Email ishidat@kchnet.or.jp

Sponsor
Institute Dept. of Respiratory Medicine, Kurashiki Central Hospital
Institute
Department

Funding Source
Organization Kurashiki Central Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 倉敷中央病院(岡山)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 10 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 Open public recruiting
Date of protocol fixation
2010 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is prospective observational study.
Patients with pneumonia in Kurashiki Central Hospital are enrolled.

Management information
Registered date
2010 Year 10 Month 07 Day
Last modified on
2010 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005195

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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