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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010588
Receipt No. R000012370
Scientific Title Retrospective study on drug interaction of tuberculosis and pulmonary Mycobacterium avium complex disease therapeutic drugs by using data of clinical symptoms and laboratory test results.
Date of disclosure of the study information 2013/04/24
Last modified on 2016/04/29

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Basic information
Public title Retrospective study on drug interaction of tuberculosis and pulmonary Mycobacterium avium complex disease therapeutic drugs by using data of clinical symptoms and laboratory test results.
Acronym Retrospective study on drug interaction of tuberculosis and pulmonary Mycobacterium avium complex disease therapeutic drugs by using data of clinical symptoms and laboratory test results.
Scientific Title Retrospective study on drug interaction of tuberculosis and pulmonary Mycobacterium avium complex disease therapeutic drugs by using data of clinical symptoms and laboratory test results.
Scientific Title:Acronym Retrospective study on drug interaction of tuberculosis and pulmonary Mycobacterium avium complex disease therapeutic drugs by using data of clinical symptoms and laboratory test results.
Region
Japan

Condition
Condition Tuberculosis and pulmonary Mycobacterium avium complex disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To retrospectively investigate influence that enzyme induction of rifampicin gives to the effect of each diabetes therapeutic drug.
2) To retrospectively investigate influence that interaction of rifampicin and clarithromycin gives to the effect and side effect frequency of pulmonary Mycobacterium avium complex disease therapeutic drugs.
3) To retrospectively investigate influence that interaction of clarithromycin and levofloxacin gives to the effect of pulmonary Mycobacterium avium complex disease therapeutic drugs.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1) Study on interaction with rifampicin and diabetes therapeutic drugs in tuberculosis patients: blood glucose and hemoglobin A1c level.
2) Study on interaction with rifampicin and clarithromycin in pulmonary Mycobacterium avium complex disease patients: clinical symptoms of subjects (cough, sputum and hemosputum etc. ), chest radiographic findings, examination of sputum (smear and culture) and clinical laboratory test results.
3) Study on interaction with clarithromycin and levofloxacin in pulmonary Mycobacterium avium complex disease patients: clinical outcome of subjects (smear and culture test).
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Study on interaction with rifampicin and diabetes therapeutic drugs in tuberculosis patients: tuberculosis patients with diabetes who administered rifampicin from 2008 to 2012.
2) Study on interaction with rifampicin and clarithromycin in pulmonary Mycobacterium avium complex disease patients: pulmonary Mycobacterium avium complex disease patients who received drug therapy from 2008 to 2012.
3) Study on interaction with clarithromycin and levofloxacin in pulmonary Mycobacterium avium complex disease patients: pulmonary Mycobacterium avium complex disease patients who received drug therapy from 2010 to 2012.
Key exclusion criteria None.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Aoyama
Organization Tokyo University of Science
Division name Faculty of Pharmaceutical Sciences
Zip code
Address 2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL 04-7124-1501
Email t-aoyama@rs.noda.tus.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Aoyama
Organization Tokyo University of Science
Division name Faculty of Pharmaceutical Sciences
Zip code
Address 2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL 04-7124-1501
Homepage URL
Email t-aoyama@rs.noda.tus.ac.jp

Sponsor
Institute Laboratory of pharmacotherapeutics, Tokyo University of Science
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Chemotherapy research institute, Kaken hospital
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 04 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4728750/
Number of participants that the trial has enrolled
Results
Our study suggests that the combination of CAM and LVFX causes unfavorable clinical outcomes for pulmonary MAC disease treatment.
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
2013 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 24 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1) Study on interaction with rifampicin and diabetes therapeutic drugs in tuberculosis patients: blood glucose and hemoglobin A1c level.
2) Study on interaction with rifampicin and clarithromycin in pulmonary Mycobacterium avium complex disease patients: clinical symptoms of subjects (cough, sputum and hemosputum etc. ), chest radiographic findings, examination of sputum (smear and culture) and clinical laboratory test results.
3) Study on interaction with clarithromycin and levofloxacin in pulmonary Mycobacterium avium complex disease patients: clinical outcome of subjects (smear and culture test).

Management information
Registered date
2013 Year 04 Month 24 Day
Last modified on
2016 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012370

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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