UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011271 |
|---|---|
| Receipt number | R000013123 |
| Scientific Title | Special Investigation - Efficacy/Safety Evaluation of Clarithromycin in Patients With Non-tuberculous Mycobacterial Pulmonary Infections |
| Date of disclosure of the study information | 2013/07/25 |
| Last modified on | 2013/12/10 16:14:37 |
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Basic information
Public title
Special Investigation - Efficacy/Safety Evaluation of Clarithromycin in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Acronym
Special Investigation of Clarithromycin in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Scientific Title
Special Investigation - Efficacy/Safety Evaluation of Clarithromycin in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Scientific Title:Acronym
Special Investigation of Clarithromycin in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Region
| Japan |
Condition
Condition
NTM Pulmonary Infections
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of adverse event,
Rate of bacterial eradication
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients given a diagnosis of NTM on the basis of criteria established by the Japanese Society for Tuberculosis (2008 Revision)
Key exclusion criteria
(i) Patients with HIV-1 infection
(ii) Patients whose pneumonia recurred within CAM treatment
(iii) Patients enrolled in entry of the study
(iv) Patients whose diseases have contraindication against the CAM
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Kadota |
Organization
Oita University Faculty of Medicine
Division name
Respiratory Medicine and Infectious Diseases
Zip code
Address
1-1Hasama,Yufu-city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Oita University Faculty of Medicine
Division name
Respiratory Medicine and Infectious Diseases
Zip code
Address
1-1Hasama,Yufu-city
TEL
Homepage URL
Sponsor or person
Institute
Junichi Kadota
Institute
Department
Personal name
Funding Source
Organization
Taisho Pharmaceutical Co.Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2013 | Year | 07 | Month | 25 | 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
Completed
Date of protocol fixation
| 2008 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2013 | Year | 07 | Month | 25 | Day |
Last modified on
| 2013 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013123
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
