UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007884 |
|---|---|
| Receipt number | 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 09:42:20 |
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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
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
shu-taga@umin.org
Sponsor or person
Institute
Daiyukai General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009287
