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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016615
Receipt No. 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

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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
Email 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
Email kkyamsaki1019@yahoo.co.jp

Sponsor
Institute Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019286

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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