UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of causative pathogens of pneumonia using bacterial floral analysis (Evaluation of the relationship between oral hygiene status and detected bacterial species in oral and lower respiratory tract specimens in pneumonia)
Acronym	Evaluation of the relationship between oral hygiene status and detected bacterial species in oral and lower respiratory tract specimens in pneumonia
Scientific Title	Evaluation of causative pathogens of pneumonia using bacterial floral analysis (Evaluation of the relationship between oral hygiene status and detected bacterial species in oral and lower respiratory tract specimens in pneumonia)
Scientific Title:Acronym	Evaluation of the relationship between oral hygiene status and detected bacterial species in oral and lower respiratory tract specimens in pneumonia
Region	Japan

Condition
Condition	Pneumonia
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the relationship between oral hygiene status and detected bacterial species in oral and lower respiratory tract specimens in pneumonia
Basic objectives2	Others
Basic objectives -Others	epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between oral hygiene status and detected bacterial species in oral and lower respiratory tract specimens in pneumonia
Key secondary outcomes	Comparison of causative pathogens by bacterial floral analysis and cultivation method

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 pneumonia 3.Patients who are planned to undergo bronchoscopic analysis for an evaluation of causative pathogens
Key exclusion criteria	1.Patients who are going to be excluded due to the safety issues 2.Patients deemed ineligible by the attending physicians for various reasons
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Noguchi
Organization	University of Occupational and Environmental Health,japan
Division name	Department of Respiratory Medicine
Zip code	807-8555
Address	1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL	093-603-1611
Email	sn0920@med.uoeh-u.ac.jp

Public contact
Name of contact person	1st name Ryosuke Middle name Last name Hata
Organization	University of Occupational and Environmental Health,japan
Division name	Department of Respiratory Medicine
Zip code	807-8555
Address	1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL	093-603-1611
Homepage URL
Email	hata_kn@yahoo.co.jp

Sponsor
Institute	Department of Respiratory Medicine,University of Occupational and Environmental Health,japan
Institute
Department

Funding Source
Organization	Department of Respiratory Medicine,University of Occupational and Environmental Health,japan
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	University of Occupational and Environmental Health,japan
Address	1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
Tel	093-603-1611
Email	k2684@med.uoeh-u.ac.jp

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	2017 Year 06 Month 30 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	39
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	2013 Year 08 Month 01 Day
Date of IRB	2017 Year 12 Month 13 Day
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date	2019 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is prospective observational study.

Management information
Registered date	2017 Year 06 Month 28 Day
Last modified on	2019 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032038