UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief 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.
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Takao Aoyama
Organization	Tokyo University of Science
Division name	Faculty of Pharmaceutical Sciences
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	Takao Aoyama
Organization	Tokyo University of Science
Division name	Faculty of Pharmaceutical Sciences
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4728750/
Results	Our study suggests that the combination of CAM and LVFX causes unfavorable clinical outcomes for pulmonary MAC disease treatment.
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