Pulmonary Mycobacterium avium complex disease
Conditions
Interventions
None listed
Sponsors
Laboratory of pharmacotherapeutics, Tokyo University of Science
Chemotherapy research institute, Kaken hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who were diagnosed with pulmonary Mycobacterium avium complex disease. 2) Patients who needed drug therapy for pulmonary Mycobacterium avium complex disease. 3) Subjects who understood the requirements of the study and signed the informed consent forms.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The serum and sputum level of therapeutic drugs and their metabolite 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
| Measure | Time frame |
|---|---|
| The ratio of urinary 6beta-hydroxycortisol/free cortisol. | — |
Countries
Japan
Contacts
Public ContactTakao Aoyama
Tokyo University of Science Faculty of Pharmaceutical Sciences
Outcome results
None listed