pulmonary nontuberculous mycobacterial disease
Conditions
Interventions
None listed
Sponsors
Department of Respiratory Medicine, University of Tsukuba
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1, Patients who have been diagnosed with pulmonary NTM disease by the diagnostic criteria of ATS 2020 (NTM positive in sputum culture twice or culture positive in bronchial lavage fluid) before registration. 2, Patients who are not on any medication at the time of registration. In addition, at the time of enrollment in this study, the therapeutic drug must have been decided as a result of consultation and medical practice with the attending physician.
Exclusion criteria
Exclusion criteria: 1. Comorbid respiratory disease: presence of any existing clinically significant known respiratory disease other than pulmonary NTM disease. 2. Malignancy: current malignancy or history of cancer that has just gone into remission less than 12 months prior to entry. 3. Liver disease: known pre-existing unstable liver disease. 4. Cardiovascular: Patients with severe or clinically significant cardiovascular disease that cannot be controlled with standard therapy. 5. Other co-morbidities: patients with known clinically significant endocrine, autoimmune, metabolic, neurologic, renal, gastrointestinal, hepatic, or hematologic disease that cannot be controlled with standard therapy. patients receiving systemic steroids for more than 4 weeks. However, patients receiving prednisolone equivalent of 10 mg/day or less of steroids will be subject to observation. 6. Pregnancy: subjects who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is to identify the gene expression profiles in whole blood cells and serum proteins that predict the response to treatment in pulmonary NTM patients, who will be divided into a treatment (CAM+EB+RFP or EM) response group and a treatment non-response group during a 1-year observation period. Then, the validity of the biomarker will be clarified in relation to the clinical information. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of this study are to determine the effect of treatment (CAM/AZM+EB+RFP or EM) on pulmonary NTM disease by comparing the pre-treatment samples and post-treatment samples in terms of the gene expression in whole blood cells and serum protein levels. RNA-seq in this study will be performed at the University of Tsukuba. | — |
Countries
Japan
Contacts
Public ContactMasashi Matsuyama
Tsukuba university hospital Department of Respiratory Medicine
Outcome results
None listed