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

Recruitingn/aAges 18 Years - anyAllShanghai Pulmonary Hospital, Shanghai, China
NCT05824988 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The incidence and prevalence of nontuberculous mycobacteria (NTM) infections have gradually increased over the years worldwide (1-3). In China, Mycobacterium avium complex (MAC) was the most prevalent NTM specie (4), while challenged by long treatment duration, frequent drug-induced adverse events, lack of treatment alternatives, poor treatment outcome and high recurrence rate (5, 6). In order to maximize the efficacy of the few available drugs and prevent the development of drug resistance, ensuring adequate plasma drug concentrations are of importance. Despite the role of pathogen susceptibility, determined by minimum inhibitory concentration (MIC), is non-negligible, the evidences regarding its association with treatment outcome are limited, especially for rifamycin and ethambutol. The difficulties in explaining the clinical values of MIC might partially be attributed to the lack of i

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📋 Eligibility rules (as published)
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
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What it tests

  • Drug exposure
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Where

1 site
Shanghai Pulmonary Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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