Examining drug exposure and its effects on treating MAC lung disease
Drug Exposure and Minimum Inhibitory Concentration in the Treatment of Mycobacterium Avium Complex Lung Disease: a Prospective Observational Cohort Study
This study is testing how different medications for MAC lung disease affect treatment success and whether drug levels in the body influence outcomes for adults with this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05824988 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to enroll adult patients with culture-positive Mycobacterium avium complex (MAC) lung disease to assess the relationship between drug exposure and treatment outcomes. Patients will be treated with a regimen including macrolides, rifamycin, and ethambutol, with detailed demographic and clinical data collected at baseline and throughout treatment. Respiratory samples will be collected periodically to monitor mycobacterial culture positivity, while drug concentrations will be measured to develop pharmacokinetic models. The study seeks to understand the impact of minimum inhibitory concentration (MIC) on treatment efficacy and the development of drug resistance.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with culture-positive MAC lung disease who are beginning treatment at the Shanghai Pulmonary Hospital.
Not a fit: Patients who are pregnant, have mixed infections, or are currently undergoing antimycobacterial treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with MAC lung disease, potentially enhancing drug efficacy and reducing recurrence rates.
How similar studies have performed: While there is limited evidence regarding the association of MIC with treatment outcomes in MAC lung disease, similar studies have shown promise in understanding drug exposure and resistance in other infections.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Culture-positive MAC lung disease * MAC treatment at the Shanghai Pulmonary Hospital * A regimen composed of at least the core drugs, i.e., macrolides, rifamycin and ethambutol, in doses not lower than recommended according to the ATS/ERS/ESCMID/IDSA and Chinese national guidelines * Written informed consent Exclusion Criteria: * Pregnancy * Confirmed mixed infection with mycobacterial species, including M.tuberculosis and other NTM species * Ongoing with any antimycobacterial treatment for more than one month, including tuberculosis and NTM * Patients admitted to the intensive care unit * Off-label use for any study drugs, such as inhalation of amikacin
Where this trial is running
Shanghai
- Shanghai Pulmonary Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Wei Sha, MD, Prof — Shanghai Pulmonary Hospital, Shanghai, China
- Study coordinator: Wei Sha, MD, Prof
- Email: shfksw@126.com
- Phone: 86 21 65115006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.