NCT07429162尚未招募1 期
DP-QB-MYA-002 Phage Cocktail for Chronic Multidrug-Resistant (MDR) Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 1
- 主要终点
- Time to Sputum Culture Conversion (Microbiologic Response)
研究概览
简要总结
The objective of this study is to evaluate mycobacteriophage therapy using in-vitro validated mycobacteriophage DP-QB-MYA-002 in combination with conventional antimycobacterial agents for the treatment of multidrug-resistant Mycobacterium abscessus pulmonary disease, with the goal of reducing mycobacterial burden and improving pulmonary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Consent to participation
排除标准
- •non-consent to participation
研究组 & 干预措施
Treatment
Experimental
Use of Mycobacteriophage
干预措施: DP-QB-MYA-002 (Biological)
结局指标
主要结局
Time to Sputum Culture Conversion (Microbiologic Response)
时间窗: 1 year
Serial AFB smear grading and serial mycobacterial sputum cultures during and post treatment
次要结局
- Change in Volume of Sputum Production (Clinical Response)(1 year)
- Change in frequency of Cough (Clinical Response)(1 year)
- Change in FEV1 (Clinical Response)(1 year)
- Change in BMI (Clinical Response)(1 year)
- Radiographic Response(1 year)
研究者
Jenny Edwards
Doctor of Pharmacy
Alberta Health services
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