Mycobacterium avium complex pulmonary disease
Conditions
Interventions
None listed
Sponsors
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine
National Hospital Organization, Higashi-Nagoya Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with MAC-PD Patients who have been on multidrug therapy for MAC-PD for at least 12 months and meet the following criteria. -Age: 20 and older -Written consent has been obtained. The diagnostic definition of MAC-PD should meet both of the following criteria 1) and 2). 1) Clinical criteria (Both required) -Patients with respiratory or systemic symptoms. -Nodular or cavitary opacities on chest radiograph, or a computed tomography scan that shows bronchiectasis with multiple small nodules. 2) Microbiologic criteria (One of the following is met) -Positive culture results from at least two separate expectorated sputum samples. -Positive culture results from at least one bronchial wash or lavage. -Transbronchial or other lung biopsy with mycobacterial histologic features and one or more positive culture results from sputum, bronchial washing, or lung biopsy In this study, it is assumed that patients are still on multidrug therapy at the time of study registration, but patients who are discontinued after 12 months of therapy due to difficulty in controlling the disease of MAC-PD can be enrolled. 2. Healthy subjects Healthy people who meet the following criteria: -Age: 20 and older -Written consent has been obtained. -People without respiratory or systemic symptoms. -No obvious abnormality on chest radiograph, or a computed tomography scan. -No underlying disease under treatment or follow-up.
Exclusion criteria
Exclusion criteria: -Patients with multiple detections of mycobacteria other than MAC. -Patients with macrolide-resistant MAC detected. -Patients whose therapy was discontinued due to adverse events, drug interaction, etc. -Patients who have been treated for less than 12 months. (If the MAC detected is macrolide susceptible, this criterion is not required.) -Patients within 1 year of completing prior treatment for MAC-PD. -Patients who underwent surgery for MAC-PD within 1 year. -Patients within 1 months of recovery from an acute infection. -Patients with chronic liver damage due to HBV or HCV. -HIV-positive patients. -Patients previously treated with immune checkpoint inhibitors for malignant tumors. -Patients with active hematologic malignancies. -Patients after blood stem cell transplants, including bone marrow transplants. -Patients treated for co-morbidities with high-dose glucocorticoid or immunosuppressive drugs. -Super-elderly people over 90 years old. -Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Clinical outcome Treatment failure of MAC-PD under the standard treatment. 2) Immunological outcome Host immune characteristics in treatment failure of MAC-PD under standard treatment. | — |
Countries
Japan
Contacts
Public ContactAkinobu Matsuura
Nagoya University Graduate School of Medicine Department of Respiratory Medicine
Outcome results
None listed