UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for personalized medicine based on pharmacokinetics and pharmacodynamics concerned with therapeutic drug of nontuberculous mycobacterium.
Title of the study (Brief title)	Study of NTM PK/PD
Region	Japan

Condition
Condition	patients administered with therapeutic drug of nontuberculous mycobacterium
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Study for personalized medicine based on pharmacokinetics and pharmacodynamics concerned with therapeutic drug of nontuberculous mycobacterium
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Study for personalized medicine with therapeutic drug of nontuberculous mycobacterium
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who were given EB, CAM, RFP judged that administration was necessary by a chief physician
Key exclusion criteria	(1) It is the patient with a history of the drug allergy in EB, CAM, RFP (2) HIV infection therapeutic drug (indinavir sulfate ethanol addition, saquinavir mesilate, nelfinavir mesilate, L biTaegu rabbi a type of radical preparation including), voriconazole, praziquantel, Tadalafil, terra pre-building, Japanese hawfinch pre-building sodium, pimozide, ergotamine component preparation, the patients receiving etc., (3) In the patients with impaired liver or kidney, it is the patient receiving the colchicine (4) The patients with biliary tract obstruction or the serious liver damage (5) Optic neuritis, patients with diabetes, patients with alcoholism (6) For an infection related to this medicine insusceptibility pathogen or resistant strain, it is the patient who is judged clinically when it is hard to expect an effect with this medicine (7) Pregnant woman, the patients nursing, the patients who may be pregnant (8) In addition, the patients who judged that it was inadequate as an object of this study
Target sample size	10

Research contact person
Name of lead principal investigator	Naoki Hasegawa
Organization	Center for Infectious Diseases and Infection Control Keio University Hospital
Division name	Center for Infectious Diseases and Infection Control
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	0333531211
Email	osamu.iketani@adst.keio.ac.jp

Public contact
Name of contact person	Osamu Iketani
Organization	Center for Infectious Disease and Infection Control
Division name	Center for Infectious Disease and Infection Control
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	0333531211
Homepage URL
Email	osamu.iketani@adst.keio.ac.jp

Sponsor
Institute	Center for Infectious Disease and Infection Control
Institute
Department

Funding Source
Organization	Center for Infectious Disease and Infection Control
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2015 Year 12 Month 31 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 12 Month 09 Day
Anticipated trial start date	2015 Year 12 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study for personalized medicine based on pharmacokinetics and pharmacodynamics concerned with therapeutic drug of nontuberculous mycobacterium

Management information
Registered date	2015 Year 12 Month 30 Day
Last modified on	2017 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023244