ACTRN12618001831279招募中2 期
Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- All
入选标准
- •Intervention Cohort Inclusion Criteria:
- •Subjects meeting all 3 ATS clinical, radiological and microbiological criteria for MABS pulmonary disease (PD) and who have confirmed MABS isolates will be eligible for randomisation into the intervention cohort. There is no minimum or maximum eligible age for participation. Subjects with mixed NTM infections (slow growers + MABS) will also be recruited as adding ethambutol will be permitted if required by the treating physician. Subjects with recurrence of MABS infection following completion of previously successful treatment will be eligible as there is strain-typing evidence that recurrence is usually associated with a new isolate.
- •Observation Cohort Inclusion Criteria:
- •Subjects who do not meet ATS criteria for MABS-PD but have a positive MABS respiratory culture, or participants who meet the criteria for MABS-PD but are not commencing MABS treatment are eligible for the observation cohort and will receive all the same outcome measures. If at a later point these participants meet the ATS criteria for MABS-PD or commence MABS treatment these subjects may be randomised into the intervention cohort.
排除标准
- •Receiving active treatment for MABS within the previous 12 months, except azithromycin for participants with cystic fibrosis and bronchiectasis.
研究者
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