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临床试验/NCT00367913
NCT00367913已完成4 期

Treatment of Pulmonary Disease Caused by MAIS, M.Xenopi or M.Malmoense: A Comparison of Two Triple Drug Regimens and an Assessment of the Value of Immunotherapy With M.Vaccae

British Thoracic Society2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 1995年3月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
400
试验地点
2
主要终点
Unwanted effects of therapy

研究概览

简要总结

To date key drugs in the treatment of MAIS, M.malmoense and M.xenopi (Opportunist Mycobacteria have been rifampicin and ethambutol. Clarithromycin and Ciprofloxacin are active in vitro against these species of mycobacteria. The primary aim of this study was to compare these to agents as supplements to rifampicin and ethambutol. A secondary aim was to assess the vale of immunotherapy with M.vaccae.

研究设计

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

入排标准

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

入选标准

  • Patients with pulmonary disease due to M.avium intracellulare, M.malmoense or M.xenopi. Aged 16 or over. With clinical and/or radiological evidence of active infection and producing sputum positive on culture on at least 2 occasions.

排除标准

  • Pregnant women and women of childbearing age not taking adequate contraceptive precautions.
  • Patients who have sputum currently positive on culture for M.tuberculosis or M.bovis.
  • Patients who have AIDS or who are known to be HIV positive

结局指标

主要结局

Unwanted effects of therapy

Death rates

Cure rates

Relapse rates

次要结局

  • Benefit or not of immunotherapy with M.vaccae

研究者

发起方
British Thoracic Society
申办方类型
Other

研究点 (2)

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