UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical prediction rule for community-acquired pneumonia in the elderly
Title of the study (Brief title)	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	Toshihiko Takada
Organization	Kyoto University School of Public Health
Division name	Department of Healthcare Epidemiology
Address	Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan
TEL	075-753-4646
Email	ttakada5000@gmail.com

Public contact
Name of contact person	Toshihiko Takada
Organization	Kyoto University School of Public Health
Division name	Department of Healthcare Epidemiology
Address	Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan
TEL	075-753-4646
Homepage URL
Email	ttakada5000@gmail.com

Sponsor
Institute	Department of Healthcare Epidemiology, School of Public Health, Kyoto University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017110