UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008731 |
|---|---|
| Receipt number | R000010257 |
| Scientific Title | Significance of respiratory microbes in acute exacerbation of chronic obstructive pulmonary disease(COPD) and bronchial asthema detected by the comprehensive realtime PCR method |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2013/05/07 08:46:30 |
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Basic information
Public title
Significance of respiratory microbes in acute exacerbation of chronic obstructive pulmonary disease(COPD) and bronchial asthema detected by the comprehensive realtime PCR method
Acronym
Significance of respiratory microbes in acute exacerbation of chronic obstructive pulmonary disease(COPD) and bronchial asthema detected by the comprehensive realtime PCR method
Scientific Title
Significance of respiratory microbes in acute exacerbation of chronic obstructive pulmonary disease(COPD) and bronchial asthema detected by the comprehensive realtime PCR method
Scientific Title:Acronym
Significance of respiratory microbes in acute exacerbation of chronic obstructive pulmonary disease(COPD) and bronchial asthema detected by the comprehensive realtime PCR method
Region
| Japan |
Condition
Condition
Acute exacerbation of a chronic airway inflammation disease(COPD/bronchial asthma)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.The pathogenic microbe which is related in acute exacerbation of two chronic airway inflammation diseases (COPD/bronchial asthma) is clarified
2.In addition,clinical isolation of M. pneumonia and antimicrobial susceptibility testing among culture positive cases is tried,although the macrolide-resistant strains increasing in recent years.And we would show the antimicrobial recommendation of M.pneumoniae.
Basic objectives2
Others
Basic objectives -Others
Detection of 18 sorts of respiratory microbes (six sorts of bacteria, 12 sorts of viruses) is done by a comprehensive genetic detection method among the acute exacerbation of two chronic airway inflammation diseases (COPD/bronchial asthma) of adult.
We would show the pathogenic microbe which is related to acute exacerbation, and then the medical treatment strategy about acute exacerbation of these chronic airway inflammation disease based on these analysis results.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Detection of 18 sorts of respiratory microbes(six sorts of bacteria,12 sorts of viruses)is done by a comprehensive genetic detection method among the acute exacerbation of two chronic airway inflammation diseases(COPD/bronchial asthma)of adult.
We would show the pathogenic microbe which is related to acute exacerbation,and then the medical treatment strategy about acute exacerbation of these chronic airway inflammation disease based on these analysis results.
2.In addition, clinical isolation of M. pneumonia and antimicrobial susceptibility testing among culture positive cases is tried, although the macrolide-resistant strains increasing in recent years. And we would show the antimicrobial recommendation of M. pneumoniae.
Key secondary outcomes
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.The adult patient who is diagnosed as COPD/bronchial asthma(BA)
2.The patient who is diagnosed as acute exacerbation of COPD BA due to acute respiratory symptoms,such as fever, sputum and dyspnea.
3.Within than seven days from the
onset.
4.No previously prescribed any antimicrobial agent other than macrolide.
5.Agree with the informed and consent of this study.
Key exclusion criteria
1.It has passed more than seven days from the onset.
2.Taking of antimicrobial agents other than macrolide
3.Disagree with the informed and consent of this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichiro Shimizu |
Organization
Jikei University School of Medicine
Division name
Respiratory medicine
Zip code
Address
3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo, 105-8471
TEL
03-3433-1111(3271-2)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Shimizu |
Organization
Jikei University School of Medicine
Division name
Respiratory medicine
Zip code
Address
3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo,
TEL
03-3433-1111(3271-2)
Homepage URL
kennet29jp@yahoo.co.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitasato University, Kitasato Institute for life science
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京慈恵会医科大学(東京都)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 01 | 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
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
1.Detection of 18 sorts of respiratory microbes(six sorts of bacteria,12 sorts of viruses)is done by a comprehensive genetic detection method among the acute exacerbation of two chronic airway inflammation diseases(COPD bronchial asthma)of adult.
We would show the pathogenic microbe which is related to acute exacerbation, and then the medical treatment strategy about acute exacerbation of these chronic airway inflammation disease based on these analysis results.
2.In addition, clinical isolation of M. pneumonia and antimicrobial susceptibility testing among culture positive cases is tried, although the macrolide-resistant strains increasing in recent years.And we would show the antimicrobial recommendation of M. pneumoniae.
Management information
Registered date
| 2012 | Year | 08 | Month | 20 | Day |
Last modified on
| 2013 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010257
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
