Study on drug concentration in serum and sputum and clinical effects in patients receiving long-term drug therapy of pulmonary Mycobacterium avium complex disease.
- Conditions
- Pulmonary Mycobacterium avium complex disease
- Registration Number
- JPRN-UMIN000010744
- Lead Sponsor
- aboratory of pharmacotherapeutics, Tokyo University of Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
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
- Primary Outcome Measures
Name Time Method Serum and sputum concentration of therapeutic drugs and their metabolites for pulmonary Mycobacterium avium complex disease. Clinical symptoms of subjects (cough, sputum and hemosputum etc.), chest radiographic findings, examination of sputum (smear and culture) and clinical laboratory test results.
- Secondary Outcome Measures
Name Time Method The ratio of urinary 6beta hydroxycortisol/free cortisol.