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
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
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
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
