UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016615 |
|---|---|
| Receipt number | R000019286 |
| Scientific Title | Open randomized controlled trial to evaluate efficacy of clindamycin in the pulmonary Mycobacterium avium complex disease |
| Date of disclosure of the study information | 2015/02/23 |
| Last modified on | 2015/02/23 23:12:25 |
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Basic information
Public title
Open randomized controlled trial to evaluate efficacy of clindamycin in the pulmonary Mycobacterium avium complex disease
Acronym
Open randomized controlled trial to evaluate efficacy of clindamycin in the pulmonary Mycobacterium avium complex disease
Scientific Title
Open randomized controlled trial to evaluate efficacy of clindamycin in the pulmonary Mycobacterium avium complex disease
Scientific Title:Acronym
Open randomized controlled trial to evaluate efficacy of clindamycin in the pulmonary Mycobacterium avium complex disease
Region
| Japan |
Condition
Condition
Pulmonary Mycobacterium avium complex disease
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of clindamycin in patients with pulmonary Mycobacterium avium complex disease in Adults
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Findings of chest high resolution computed tomography before and after clindamycin treatment
Key secondary outcomes
1. Symptoms, laboratory data, spirometry
2. Bacteriological efficacy: sputum culture, and bacterial floral analysis findings of bronchoalveolar lavage fluid culture
3. Safety and adverse effects of clindamycin treatment
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of clarithromycin, rifampicin, ethambutol.
Interventions/Control_2
After oral administration of clarithromycin, rifampicin, ethambutol for month, add oral administration of clindamycin for two months.
Interventions/Control_3
Follow up.
Interventions/Control_4
After oral administration of clindamycin for three months, follow up.
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
1. Patients 20 years of age and older
2. Patients satisfying diagnostic riteria of nontuberculous mycobacteriosis and causative pathogens are Mycobacterium avium or M. intracellulare
Key exclusion criteria
1. Patients receiving other antibiotic treatments.
2. Contraindication for clindamycin, clarithromycin, rifampicin, ethambutol administration
3. Patients deemed ineligible by the attending physicians for various reasons.
4. Patients with serious heart disorders
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Yamasaki |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Respiratory Medicine
Zip code
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL
093-603-1611
kkyamsaki1019@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Yamasaki |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Respiratory Medicine
Zip code
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL
093-603-1611
Homepage URL
kkyamsaki1019@yahoo.co.jp
Sponsor or person
Institute
Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
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
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
| 2015 | Year | 02 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 23 | Day |
Last modified on
| 2015 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019286
