UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000025317