Mycobacterium avium complex pulmonary disease and Mycobacterium abscessus complex pulmonary disease
Conditions
Interventions
Experimental group:Clofazimine
Sponsors
Beijing Chest Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-75, gender unlimited; (2) MAC-PD or MABC-PD were diagnosed; (3) Chest imaging found lung lesions with or without cavities; (4) The patient was not suitable for standard MAC-PD and MABC-PD treatment, including anti-tuberculosis treatment in the last 3 years, use of drugs that interact with rifampicin, and a high risk of adverse effects to the standard regimens; (5) Women of childbearing age who had a negative urine test and agreed to use highly effective contraception during the study period; (6) Those who agree to participate in the experiment and have signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) Anti-MAC-PD and MABC-PD have been treated for more than 1 month before this visit; (2) At the beginning of treatment, ALT exceeded the upper limit of normal by 2 times or creatinine exceeded the upper limit of normal; (3) long-term use of immunosuppressant; (4) Patients with other serious underlying diseases; (5) Lactation or pregnancy; (6) Karnofsky score < 50; (7) According to the judgment of the research group, the subject suffers from any disease that is not suitable for participating in this subject ; (8) Those who have a history of mental illness or fail to pass the psychiatric evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum inhibitory concentrations of clinical isolates of MAC and MABC;Clofazimine Cmax;Area under the curve of clofazimine plasma concentration from 0 hours to 8 hours; | — |
Countries
China
Contacts
Public ContactDuan Hongfei; Bao Shengjuan
Beijing Chest Hospital, Capital Medical University
Outcome results
None listed