MAC Pulmonary Disease
Conditions
Interventions
Experimental group:Drug sensitivity test of Clofazimine and Macrolide
Sponsors
Beijing Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, gender is not limited; 2. Diagnosed with Mycobacterium avium complex lung disease; 3. Chest imaging examination found intrapulmonary lesions, with or without cavities; 4. The patient is not suitable for the standard MAC lung disease treatment regimen, including receiving anti-tuberculosis treatment in the past 3 years, using drugs that interact with rifampicin, and the standard regimen has a high risk of adverse reactions; 5. Women of childbearing age have a negative pregnancy urine test and agree to use high-efficiency contraceptive measures during the study; 6. Those who agree to participate in the trial and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Anti-MAC therapy has been started for more than 1 month before the visit; 2. Drug susceptibility test indicates macrolide resistance, or macrolide resistance gene mutation is found, or macrolide treatment for more than 6 months in the past 3 years; 3. Alanine aminotransferase exceeding 2 times the upper limit of normal or creatinine exceeding the upper limit of normal at the beginning of treatment; 4. Long-term use of immunosuppressants; 5. Those with other serious underlying diseases; 6. Lactation or pregnancy; 7. Karnofsky score <50; 8. According to the judgment of the research team, the subject suffers from any disease that is not suitable for participating in this subject or may prevent the patient from participating in the whole process of this subject; 9. Those who have a history of mental illness or those who fail the mental assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum inhibitory concentrations of clinical isolates of Mycobacterium avium complex;Clofazimine Cmax;Area under the curve of clofazimine plasma concentration from 0 hours to 8 hours; | — |
Countries
China
Contacts
Public ContactDuan Hongfei
Beijing Chest Hospital
Outcome results
None listed