Condition: Mycobacterium Avium Complex · Mycobacterium Avium-Intracellulare Infection · Gram-Positive Bacterial Infections · Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
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 in vivo drug exposure data, which cannot be accurately predicted by the dose administered because of between-patient pharmacokinetic variability (7). Therapeutic drug monitoring (TDM) is a strategy to guide and personalize treatment by measuring plasma drug concentrations and pathogen susceptibility, which might have the potential to improve treatment response to MAC lung disease. In this observational study, the hypothesis is that the drug exposure and/or MIC of antimycobacterial drugs are correlated to the treatment response of MAC lung disease, which is assessed from the perspective of trea…
This description comes directly from the study's public registry record.
Wei Sha, MD, Prof · 86 21 65115006 · shfksw@126.com
Xubin Zheng, MPH, PhD · 86 21 65115006 · xbzheng@tongji.edu.cn
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| Shanghai Pulmonary Hospital | Shanghai, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05824988