UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027968 |
|---|---|
| Receipt number | R000032038 |
| 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) |
| Date of disclosure of the study information | 2017/06/30 |
| Last modified on | 2019/07/30 17:22:54 |
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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
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
hata_kn@yahoo.co.jp
Sponsor or person
Institute
Department of Respiratory Medicine,University of Occupational and Environmental Health,japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032038
