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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002819
Receipt No. R000002135
Scientific Title Efficacy and safety of Clarithromycin(CAM)/Ethambutol(EB) versus Rifampicin(RIF)/Clarithromycin(CAM)/Ethambutol(EB) in Mycobacterium avium Complex(MAC): a randomized, open-label, multicenter study
Date of disclosure of the study information 2009/12/01
Last modified on 2012/05/01

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Basic information
Public title Efficacy and safety of Clarithromycin(CAM)/Ethambutol(EB) versus Rifampicin(RIF)/Clarithromycin(CAM)/Ethambutol(EB) in Mycobacterium avium Complex(MAC): a randomized, open-label, multicenter study
Acronym Efficacy and safety of Clarithromycin(CAM)/Ethambutol(EB) versus Rifampicin(RIF)/Clarithromycin(CAM)/Ethambutol(EB) in Mycobacterium avium Complex(MAC): a randomized, open-label, multicenter study
Scientific Title Efficacy and safety of Clarithromycin(CAM)/Ethambutol(EB) versus Rifampicin(RIF)/Clarithromycin(CAM)/Ethambutol(EB) in Mycobacterium avium Complex(MAC): a randomized, open-label, multicenter study
Scientific Title:Acronym Efficacy and safety of Clarithromycin(CAM)/Ethambutol(EB) versus Rifampicin(RIF)/Clarithromycin(CAM)/Ethambutol(EB) in Mycobacterium avium Complex(MAC): a randomized, open-label, multicenter study
Region
Japan

Condition
Condition Mycobacterium avium Complex(MAC) without HIV
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficacy and safety of Clarithromycin/Ethambutol for Mycobacterium avium Complex(MAC).
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes chest Xray, HRCT, bacteriologic evaluation, clinical symptom
Key secondary outcomes the serum and intracellular concentration of Clarithromycin, Clarithromycin resistance of MAC

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Body weight is over 40kg.
Rifampicin 450mg/day
Clarithromycin 600mg/day
Ethambutol 750mg/day
Body weight is under 40kg.
Rifampicin 300mg/day
Clarithromycin 400mg/day
Ethambutol 500mg/day
Duration
One year.
Interventions/Control_2 Body weight is over 40kg.
Clarithromycin 600mg/day
Ethambutol 750mg/day
Body weight is under 40kg.
Clarithromycin 400mg/day
Ethambutol 500mg/day
Duration
One year.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Meeting diagnostic criteria for MAC infection described in "Am J Respir Crit Care Med Vol.175. p367-416".
Written informed consent obtained.
Key exclusion criteria ECOG performance status 3-4.
Patients with HIV infection.
Patients with history of treatment for MAC infection.
Patients with any undelying disease considered tohave a significant impact on the course of treatment in this clinical study such as progressive cancer.
Patients receiving immunosuppressive drug.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kinngo Chida
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1Handayama Hamamatu Japan
TEL 053-435-2354
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro shirai
Organization National hospital Organization Tenryu Hospital
Division name respiratory medicine
Zip code
Address 4201-2 Oro Hamakitaku Hamamatsu Shizuoka Japan
TEL 053-583-3111
Homepage URL http://www.tenryu-hosp.jp/
Email shiraim@smail.plala.or.jp

Sponsor
Institute Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization National hospital Organization Tenryu Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
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 浜松医科大学第2内科(静岡県)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 01 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
2006 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 04 Month 01 Day
Date trial data considered complete
2011 Year 04 Month 01 Day
Date analysis concluded
2011 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 12 Month 01 Day
Last modified on
2012 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002135

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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