UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002819 |
|---|---|
| Receipt number | 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 15:15:00 |
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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
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/
shiraim@smail.plala.or.jp
Sponsor or person
Institute
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002135
