UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010588
Receipt number 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 15:24:45

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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 or person

Institute

Laboratory of pharmacotherapeutics, Tokyo University of Science

Institute

Department

Personal name



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

Value
https://center6.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