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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007884
Receipt No. R000009287
Scientific Title Prospective clinical study and genetic research for the patients with pulmonary Mycobacterium avium complex disease to investigate the infection source, infection route, and pathogenesis of Mycobacterium avium complex.
Date of disclosure of the study information 2012/05/07
Last modified on 2014/12/02

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Basic information
Public title Prospective clinical study and genetic research for the patients with pulmonary Mycobacterium avium complex disease to investigate the infection source, infection route, and pathogenesis of Mycobacterium avium complex.
Acronym Prospective clinical study and genetic research for the patients with pulmonary Mycobacterium avium complex disease to investigate the infection source, infection route, and pathogenesis of Mycobacterium avium complex.
Scientific Title Prospective clinical study and genetic research for the patients with pulmonary Mycobacterium avium complex disease to investigate the infection source, infection route, and pathogenesis of Mycobacterium avium complex.
Scientific Title:Acronym Prospective clinical study and genetic research for the patients with pulmonary Mycobacterium avium complex disease to investigate the infection source, infection route, and pathogenesis of Mycobacterium avium complex.
Region
Japan

Condition
Condition Pulmonary Mycobacterium avium complex disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The aim of this prospective clinical study and genetic research for the untreated patients with pulmonary Mycobacterium avium complex disease is to investigate the infection source, infection route, and pathogenesis of Mycobacterium avium complex.
Basic objectives2 Others
Basic objectives -Others The aim of this prospective clinical study and genetic research for the untreated patients with pulmonary Mycobacterium avium complex disease is to investigate whether the patient's residential bathroom is one of the sources and routes of Mycobacterium avium complex infection or not by assessing the patients' clinical features and using variable- number tandem- repeat analysis for Mycobacterium avium complex strains from the patient's sputum and residential bathroom. The predictor of exacerbations of pulmonary Mycobacterium avium complex disease and the responsiveness for treatments are also assessed by research of gene insertion sequence in Mycobacterium avium complex.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To investigate whether the patient's residential bathroom is one of the sources and routes of Mycobacterium avium complex infection or not by assessing the patients' clinical features and using variable- number tandem- repeat analysis for Mycobacterium avium complex strains from patient's sputum and residential bathroom.
Key secondary outcomes To investigate the predictor of exacerbations of pulmonary Mycobacterium avium complex disease and the responsiveness for treatments by research of gene insertion sequence in Mycobacterium avium complex.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Gene
Interventions/Control_1 The aim of this prospective clinical study and genetic research for the untreated patients with pulmonary Mycobacterium avium complex disease is to investigate whether the patient's residential bathroom is one of the sources and routes of Mycobacterium avium complex infection or not by assessing the patients' clinical features and using variable- number tandem- repeat analysis for Mycobacterium avium complex strains from the patient's sputum and residential bathroom. The predictor of exacerbations of pulmonary Mycobacterium avium complex disease and the responsiveness for treatments are also assessed by research of gene insertion sequence in Mycobacterium avium complex.
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 Untreated patients with pulmonary Mycobacterium avium complex disease who consent in writing.
Key exclusion criteria Treated patients with pulmonary Mycobacterium avium complex disease, and the patients who do not consent in writing.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shu Taga
Organization Local Incorporated Administrative Agency Okayama City General Medical Center Okayama City Hospital
Division name Department of Respiratory Medicine and Allergology
Zip code
Address 6-10, Amase, Kita-ku, Okayama-city, Okayama 700-8557, Japan
TEL 086-225-3171
Email shu-taga@umin.org

Public contact
Name of contact person
1st name
Middle name
Last name Shu Taga
Organization Local Incorporated Administrative Agency Okayama City General Medical Center Okayama City Hospital
Division name Department of Respiratory Medicine and Allergology
Zip code
Address 6-10, Amase, Kita-ku, Okayama-city, Okayama 700-8557, Japan
TEL 086-225-3171
Homepage URL
Email shu-taga@umin.org

Sponsor
Institute Daiyukai General Hospital
Institute
Department

Funding Source
Organization None.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Hospital Organization Higashinagoya National Hospital; Department of Microbiology, Faculty of Pharmacy, Meijo University; Nagoya University Hospital
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

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
"Nontuberculous Mycobacteria isolation out of residential bathrooms of untreated patients with pulmonary Mycobacterium avium complex disease" was presented at the 88th Anual Meeting of the Japanese Society for tuberclosis (Mar 28-29, 2013).

"Comparisons of clinical backgrounds between patients with and without recovery of MAC isolates from residential bathrooms of untreated Japanese patients with pulmonary MAC disease" was presented at the 110th Anual Meeting of the Japanese Society of Internal Medicine (Apr 11, 2013).

"Differences of backgrounds between patients with Mycobacterium avium lung disease and with Mycobacterium intracellulare lung disease" was presented at the 28th International Congress of Chemothrapy and Infection (Jun 05-06, 2013).

"Incidence of Nontuberculous Mycobacteria isolation out of residential bathrooms of untreated patients with pulmonary Mycobacterium avium complex disease" was presented at the 18th Congress of the APSR (Nov 11-14, 2013).

"Analysis of characteristics of Mycobacterium avium isolates recovered from sputum and residential bathroom using VNTR typing method and BrothMIC NTM" was presented at the 67th Annual Meeting of Japanese Society of National Medical Services (Nov 8-9, 2013).

"Analysis of VNTR patterns of Mycobacterium avium complex isolates recovered from patients with pulmonary MAC disease and their residential bathrooms" was presented at the 88th Annual Meeting of Japanese Association for Infectious Diseases (Jun 18-20, 2014).

"Genetic Analyses of Mycobacterium avium Complex Isolates Recovered from Patients with Pulmonary MAC Disease and Their Residential Bathrooms" is scheduled to be presented at the 90th Anual Meeting of the Japanese Society for tuberclosis (Mar 27-28, 2015).
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
2011 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
2015 Year 11 Month 30 Day
Date analysis concluded
2015 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2012 Year 05 Month 02 Day
Last modified on
2014 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009287

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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