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临床试验/NCT07514364
NCT07514364招募中4 期

The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance: a Randomized Study

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
60
试验地点
1

研究概览

简要总结

Background: Mycobacterium abscessus, one of the most common species of nontuberculous mycobacterium (NTM), poses a significant clinical challenge due to its natural resistance to antibiotics and high treatment failure rates, particularly in lung diseases. Among its subspecies, M. abscessus subspecies abscessus is especially prone to developing inducible resistance to Clarithromycin. This resistance mechanism is primarily due to the activation of the erm(41) gene,which inhibits Clarithromycin from effectively binding to the bacterial ribosome, diminishing its bactericidal efficacy. Rifabutin, an antibiotic widely used in treating tuberculosis and certain NTM infections, has been shown to inhibit the activation of the erm(41) gene by suppressing the whiB7 protein in M. abscessus, suggesting potential efficacy against inducible resistance. However,current evidence primarily stems from in vitro susceptibility studies and case reports, with a notable lack of systematic clinical trials.

详细描述

Specific Aims: The primary aim of this study is to evaluate the efficacy and safety of Rifabutin in treating M. abscessus lung disease with inducible Clarithromycin resistance. Specific objectives include:

  • Assessing sputum culture conversion rates and clinical improvement when Rifabutin is added to the standard treatment regimen.
  • Investigating the effect of Rifabutin on progression-free survival (PFS).
  • Evaluating patient tolerance and adverse events throughout treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged ≥ 18 years
  • Diagnosis of pulmonary disease caused by Mycobacterium abscessus confirmed by clinical evaluation and laboratory results
  • Antimicrobial susceptibility testing indicating inducible resistance to clarithromycin
  • Clinically stable and suitable for antibiotic treatment
  • Radiographic evidence of active pulmonary infection
  • Willing and able to provide informed consent

排除标准

  • Known hypersensitivity to rifabutin or intolerance to other study medications
  • Pregnant or breastfeeding women

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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