Observational Study of Drug Levels and Bacterial Resistance in Treating Mycobacterium Avium Complex Lung Disease

What this Trial Is About

Researchers are studying Mycobacterium avium complex MAC lung disease, a type of nontuberculous mycobacteria infection that has become more common worldwide. This observational study aims to understand how drug exposure and the minimum inhibitory concentration MIC of antimycobacterial drugs relate to treatment response. The study focuses on treatment outcomes, including culture conversion, lung function, radiology, and quality of life in adult patients with culture-positive MAC lung disease. Participants will receive standard treatment regimens containing macrolides, rifamycin, and ethambutol, following established international and Chinese guidelines. Respiratory samples will be collected regularly for mycobacterial culture and MIC testing. Blood samples for drug concentration measurement will be taken at one month after treatment starts, with more detailed sampling in some patients to develop pharmacokinetic models. Additional samples will be collected at six months for those with poor treatment response. Post-treatment visits at 6 and 12 months will monitor recurrence. Throughout the study, participants will undergo regular mycobacterial culture, lung function tests, CT scans, and quality-of-life questionnaires. Researchers will analyze drug exposure variables like peak plasma concentration and area under the curve, along with MIC values, to explore their association with treatment success. Treatment outcomes and adverse events will be recorded up to 18 months, and recurrence will be monitored up to 30 months after treatment completion. The total study duration includes baseline, treatment, and follow-up assessments.

Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease