UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004353 |
|---|---|
| Receipt number | 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 14:53:55 |
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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
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
ishidat@kchnet.or.jp
Sponsor or person
Institute
Dept. of Respiratory Medicine, Kurashiki Central Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005195
