UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The prospective observational study to evaluate swallowing ability in patients with Nursing and Healthcare Associated Pneumonia (NHCAP) categorized as group B or C or D according to the JRS Guidelines for the Management of Nursing and Healthcare Associated pneumonia in Adults
Title of the study (Brief title)	The prospective observational study to evaluate swallowing ability in patients with NHCAP group B/C/D according to the JRS Guidelines
Region	Japan

Condition
Condition	Nursing and Healthcare Associated Pneumonia
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate prospectively swallowing ability in patients with NHCAP categorized as group B or C or D according to the JRS Guidelines for the Management of Nursing and Healthcare Associated Pneumonia in Adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	30-day mortality
Key secondary outcomes	Relapses of pneumonia occurring within 30 days following admission

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients 20 years of age and older 2. Patients with NHCAP categorized as group B or C or D according to the JRS Guidelines for the Management of Nursing and Healthcare Associated Pneumonia in Adults
Key exclusion criteria	Patients deemed ineligible by the attending physicians for various reasons
Target sample size	100

Research contact person
Name of lead principal investigator	Tatuji Katou
Organization	Tobata Kyoritsu Hospital
Division name	Department of Respiratory Medicine
Address	2-5-1 Sawami, Tobata-ku, Kitakyushu city, Fukuoka, 804-0093, Japan
TEL	093-871-5421
Email	t-katou@kyoaikai.com

Public contact
Name of contact person	Yasuo Chojin
Organization	Tobata Kyoritsu Hospital
Division name	Department of Respiratory Medicine
Address	2-5-1 Sawami, Tobata-ku, Kitakyushu city, Fukuoka, 804-0093, Japan
TEL	093-871-5421
Homepage URL
Email	choppy001042@yahoo.co.jp

Sponsor
Institute	Department of Respiratory Medicine, Tobata Kyoritsu Hospital
Institute
Department

Funding Source
Organization	Department of Respiratory Medicine, Tobata Kyoritsu Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2015 Year 01 Month 11 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 01 Month 13 Day
Anticipated trial start date	2015 Year 01 Month 13 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	Published
URL releasing results
Results
Other related information	This study is prospective observation study. Patients with NHCAP in attending hospital are enrolled.

Management information
Registered date	2015 Year 01 Month 11 Day
Last modified on	2018 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018782