Clinical study on drug interactions and dosage administration of therapeutic drugs for nontuberculous mycobacterium infection.

Not Applicable

• Conditions: Pulmonary Mycobacterium avium complex disease

• Registration Number: JPRN-UMIN000009343
• Lead Sponsor: aboratory of pharmacotherapeutics, Tokyo University of Science

Brief Summary

Our study demonstrated consistently low levels of serum CAM due to RFP-mediated induction of CYP3A4 in pulmonary MAC disease patients treated with a standard combination of CAM and RFP. These continuously low concentrations of CAM are suggested to be responsible for unsatisfactory clinical outcomes of this disease.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-15
• Study Completion: 2016-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

1)Subjects whose PS(Performance Status)are over 7 accordance with the Ordinance of the Ministry of Health, Labour and Welfare. 2)Subjects who had in the past or currently have following diseases. ;hepatic or renal diseases ;other diseases which doctor in attendance considered to influence in results of study, or be penalized by administration of clarithromycin, rifampicin and ethambutol. 3)Subjects who consumed excessive amounts of coffee or beverage containing caffeine.(over eight cups a day) 4)Drug or alcohol abuser. 5)Illegal drug constant user. 6)Men and women who donated two hundred milliliter of blood within four weeks prior to commencement of this study, or men who donated four hundred milliliter of blood within twelve weeks prior to commencement of this study, and women who donated four hundred milliliter of blood within sixteen weeks prior to commencement of this study. 7)Subjects who participated in another clinical trials with an investigational agent within four weeks prior to commencement of this study. 8)Subjects who had history of hypersensitivity to constituent of RIFADIN CAPSULES, CLARITH TABLETS and ESANBUTOL TABLETS. 9)Subjects who are judged as inadequate by doctor in attendance.

Study & Design

• Study Type: Observational
• Study Design: Not specified