UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021956
Receipt number 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 08:42:55

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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 or person

Institute

Department of Respiratory Medicine, National Hospital Organization Ibarakihigashi National Hospital

Institute

Department

Personal name



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

Value
https://center6.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