CTIS2023-506575-99-00进行中（未招募）1 期
Finding the Optimal Regimen for Mycobacterium abscessus Treatment - FORMaT001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1.Positive MABS-PD diagnosis meeting all three American Thoracic Society clinical, radiological and microbiological diagnostic criteria for MABS-PD. Defined as: a.Clinical: Pulmonary symptoms and exclusion of other diagnoses. b.Radiological: Nodular or cavitary opacities on chest radiograph or a chest high-resolution computed tomography (HRCT) scan showing multifocal bronchiectasis with multiple small nodules. c.Microbiological: MABS positive culture results from at least two separate expectorated sputum samples. or Positive culture results from at least one bronchial wash or lavage. or Transbronchial or other lung biopsy with mycobacterial histopathologic features (granulomatous inflammation or acid-fast bacilli (AFB)) and positive culture for NTM or biopsy showing mycobacterial histopathologic features (granulomatous inflammation or AFB) and one or more sputum or bronchial washes that are culture positive for NTM. Screening samples must be collected within the timeframes stated in the relevant appendix., 2.Male or female participants of any age., 3.Participant has not received treatment for MABS-PD in the 12 months preceding assessment of eligibility or as specified in the relevant appendix (this includes drugs prescribed for the treatment of other mycobacteria and/or other indications that may have activity against MABS, as specified in FORMaT Prohibited Drug List SOP., 4.Informed consent signed by participant or parent/legal guardian if participant is under 18 years of age., 5.Ability to comply with study visits, therapies and study procedures as judged by the site investigator.
排除标准
- •Participants receiving current treatment for MABS (this includes drugs prescribed for the treatment of other mycobacteria and/or other indications that may have activity against MABS, as specified in FORMaT Prohibited Drug List SOP), except for participants taking azithromycin as part of routine treatment for CF or chronic infection-related pulmonary disease, or as specified in the relevant appendix., •Participants who have a QTc interval of >500 milliseconds (QT interval corrected based on Fridericia method)., •Participants who are pregnant or planning to continue breast feeding., •Known hypersensitivity to any of the therapies for which no alternative option(s) have been provided.
研究者
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