UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037539 |
|---|---|
| Receipt number | 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 | 2024/03/18 12:36:12 |
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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
namihei@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Nemoto |
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
kazuki585@med.uoeh-u.ac.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
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
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
| 2027 | Year | 01 | 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
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042787
