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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037539
Receipt No. R000042787
Scientific Title Evaluating the causative pathogens of pneumonia using bacterial floral analysis
Date of disclosure of the study information 2019/07/31
Last modified on 2019/07/30

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Basic information
Public title Evaluating the causative pathogens of pneumonia using bacterial floral analysis
Acronym Evaluating the causative pathogens of pneumonia using bacterial floral analysis
Scientific Title Evaluating the causative pathogens of pneumonia using bacterial floral analysis
Scientific Title:Acronym Evaluating the causative pathogens of pneumonia using bacterial floral analysis
Region
Japan

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

Objectives
Narrative objectives1 Evaluating the microbiota of pneumonia and relationship between its microbiota and viral infection using specimens obtained from pneumonia lesion
Basic objectives2 Others
Basic objectives -Others epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The frequency of detected causative pathogens in the respiratory infections such as bacterial pneumonia, lower respiratory tract infection, and viral pneumonia
Key secondary outcomes 1. Comparison of detection frequency of causative pathogens between bacterial floral analysis and cultivation method
2. The frequency of co-infection of bacteria and virus in pneumonia

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 with 20 years of age and older
2.Patients with pneumonia
3.Patients who are planned bronchoscopic analysis for an evaluation of causative pathogens
Key exclusion criteria 1.Patients who should be excluded due to the safety issues
2.Patients who are considered inappropriate by the attending physicians

Target sample size 50

Research contact person
Name of lead principal investigator
1st name Toshinori
Middle name
Last name Kawanami
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 namihei@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Ikegami
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 h_i214538y@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 Ethics Committee of Medical Research, University of Occupational and Environmental Health, Japan
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu city, Fukuoka, 807-8555, Japan
Tel 093-691-7205
Email daigakukanri@mbox.pub.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
2019 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 Open public recruiting
Date of protocol fixation
2010 Year 04 Month 01 Day
Date of IRB
2013 Year 03 Month 12 Day
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This clinical trial is a prospective observational study. Patients who meet selection criteria and do not conflict with exclusion criteria are included.

Management information
Registered date
2019 Year 07 Month 30 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/ctr_e/ctr_view.cgi?recptno=R000042787

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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