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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021956
Receipt No. R000025317
Scientific Title The evaluation of activity, inflammation, and oxidative stress in patients with nontuberculous mycobacteriosis
Date of disclosure of the study information 2016/04/20
Last modified on 2020/11/10

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Basic information
Public title The evaluation of activity, inflammation, and oxidative stress in patients with nontuberculous mycobacteriosis
Acronym Activity and oxidative stress of nontuberculous mycobacteriosis
Scientific Title The evaluation of activity, inflammation, and oxidative stress in patients with nontuberculous mycobacteriosis
Scientific Title:Acronym Activity and oxidative stress of nontuberculous mycobacteriosis
Region
Japan

Condition
Condition nontuberculous mycobacteriosis(NTM)
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of inflammation and oxidative stress in the activity of NTM. And, to elucidate which factors contribute to its disease activity and the response to antibiotics.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Oxidative stress markers (oxidants & antioxidants)
Key secondary outcomes Disease activity, Inflammatory markers (cytokines, growth factors, proteases), Circadian rhythm (molecularclock) markers, Nutrition, Pulmonary function, Exercise capacity

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Standard therapy by antibiotics(clarithromycin, rifampicin, ethambutol)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are diagnosed as NTM, as defined by the 2008 JST and JRS NTM criteria, and NTM-suspected cases due to their imaging analysis.
Key exclusion criteria 1. Patients who disagree with involving in this study
2. Patients who diagnosed as malignancy, overt cardiac failure, and hepatic and renal disease
3. Patients who are judged to be unfit to the study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name SHUJI
Middle name
Last name OH-ISHI
Organization National Hospital Organization Ibarakihigashi National Hospital
Division name Department of Respiratory Medicine
Zip code 319-1113
Address 825 Terunuma, Tokai-mura, Naka-gun, Ibaraki 319-1113, Japan
TEL +81-29-282-1151
Email ooishi.shuji.dg@mail.hosp.go.jp

Public contact
Name of contact person
1st name SHUJI
Middle name
Last name OH-ISHI
Organization National Hospital Organization Ibarakihigashi National Hospital
Division name Department of Respiratory Medicine
Zip code 319-1113
Address 825 Terunuma, Tokai-mura, Naka-gun, Ibaraki 319-1113, Japan
TEL +81-29-282-1151
Homepage URL
Email ooishi.shuji.dg@mail.hosp.go.jp

Sponsor
Institute Department of Respiratory Medicine, National Hospital Organization Ibarakihigashi National Hospital
Institute
Department

Funding Source
Organization Department of Respiratory Medicine, National Hospital Organization Ibarakihigashi National Hospital
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 National Hospital Organization Ibarakihigashi National Hospital
Address 825 Terunuma, Tokai-mura, Naka-gun, Ibaraki 319-1113, Japan
Tel +81-29-282-1151
Email yamano.yoichi.pn@mail.hosp.go.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
2016 Year 04 Month 20 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
2016 Year 01 Month 01 Day
Date of IRB
2015 Year 11 Month 05 Day
Anticipated trial start date
2016 Year 04 Month 20 Day
Last follow-up date
2021 Year 04 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information As of January 2019, 69 patients was enrolled in this study. We analysed the association between neutrophils in BALF and serum oxidative stress marker, and presented the results in the 2019 annual meeting f European Respiratory Society

Management information
Registered date
2016 Year 04 Month 18 Day
Last modified on
2020 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025317

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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