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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011271
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Junichi Kadota
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013123

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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