UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014721 |
|---|---|
| Receipt number | R000017110 |
| Scientific Title | Clinical prediction rule for community-acquired pneumonia in the elderly |
| Date of disclosure of the study information | 2014/07/31 |
| Last modified on | 2017/08/02 09:01:14 |
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Basic information
Public title
Clinical prediction rule for community-acquired pneumonia in the elderly
Acronym
Clinical prediction rule for community-acquired pneumonia in the elderly
Scientific Title
Clinical prediction rule for community-acquired pneumonia in the elderly
Scientific Title:Acronym
Clinical prediction rule for community-acquired pneumonia in the elderly
Region
| Japan |
Condition
Condition
Community-acquired pneumonia
Classification by specialty
| Medicine in general | Infectious disease | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a clinical prediction rule for community-acquired pneumonia in the elderly patient with acute respiratory symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic accuracy of the prediction rule for community-acquired pneumonia, consisting from history and physical examination.
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults aged more than or equal to 65 years
Complaint includes cough or sputum production within a month
Key exclusion criteria
Transferred from nursing homes
Transferred from another hospital
Antibiotics has been already prescribed
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Takada |
Organization
Kyoto University School of Public Health
Division name
Department of Healthcare Epidemiology
Zip code
Address
Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan
TEL
075-753-4646
ttakada5000@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Takada |
Organization
Kyoto University School of Public Health
Division name
Department of Healthcare Epidemiology
Zip code
Address
Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan
TEL
075-753-4646
Homepage URL
ttakada5000@gmail.com
Sponsor or person
Institute
Department of Healthcare Epidemiology, School of Public Health, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
St. Lukes lifescience institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kimitsu Chuo Hospital, Ashigarakami Hospital
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
君津中央病院（千葉県）、足柄上病院（神奈川）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 31 | 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
| 2014 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective study for developing a clinical prediction rule. Consecutive patients with eligibility will be included in this study.
Management information
Registered date
| 2014 | Year | 07 | Month | 31 | Day |
Last modified on
| 2017 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017110
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
