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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008731
Receipt No. 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

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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)
Email

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
Email kennet29jp@yahoo.co.jp

Sponsor
Institute Jikei University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010257

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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