A Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of a Contezolid, Delamanid and Bedaquiline-Containing Short Regimen for the Treatment of Rifampicin-Resistant Pulmonary Tuberculosis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 186
- 试验地点
- 39
- 主要终点
- Favourable outcome rate at 24 months after randomization
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy and safety of a Contezolid and Delamanid-Containing short regimen to standard longer regimen in Rifampicin-resistant pulmonary tuberculosis (RR-TB). The main questions it aims to answer are:
- Is the efficacy of short regimen non-inferior to standard regimen?
- Is the short regimen safe enough to replace the standard regimen?
Participants will:
- Be given with either short or standard regimen for RR-TB treatment
- Be asked to complete the scheduled visit as planned.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Short-Term Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ DLM CZD LFX(MFX) for 6 months
- For those resistant to FQs: BDQ DLM CZD CFZ for 6 months
干预措施: Bedaquiline (Drug)
Short-Term Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ DLM CZD LFX(MFX) for 6 months
- For those resistant to FQs: BDQ DLM CZD CFZ for 6 months
干预措施: Delamanid (Drug)
Short-Term Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ DLM CZD LFX(MFX) for 6 months
- For those resistant to FQs: BDQ DLM CZD CFZ for 6 months
干预措施: Contezolid (Drug)
Short-Term Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ DLM CZD LFX(MFX) for 6 months
- For those resistant to FQs: BDQ DLM CZD CFZ for 6 months
干预措施: Levofloxacin (Drug)
Short-Term Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ DLM CZD LFX(MFX) for 6 months
- For those resistant to FQs: BDQ DLM CZD CFZ for 6 months
干预措施: Moxifloxacin (Drug)
Short-Term Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ DLM CZD LFX(MFX) for 6 months
- For those resistant to FQs: BDQ DLM CZD CFZ for 6 months
干预措施: Clofazimine (Drug)
Standard Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ LZD LFX(MFX) CS CFZ regimen for 6 months, then LFX(MFX) CS CFZ for 12 months
- For those resistant to FQs: LFX(MFX) will be replaced by Pto, PZA, PAS or EMB
干预措施: Bedaquiline (Drug)
Standard Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ LZD LFX(MFX) CS CFZ regimen for 6 months, then LFX(MFX) CS CFZ for 12 months
- For those resistant to FQs: LFX(MFX) will be replaced by Pto, PZA, PAS or EMB
干预措施: Levofloxacin (Drug)
Standard Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ LZD LFX(MFX) CS CFZ regimen for 6 months, then LFX(MFX) CS CFZ for 12 months
- For those resistant to FQs: LFX(MFX) will be replaced by Pto, PZA, PAS or EMB
干预措施: Moxifloxacin (Drug)
Standard Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ LZD LFX(MFX) CS CFZ regimen for 6 months, then LFX(MFX) CS CFZ for 12 months
- For those resistant to FQs: LFX(MFX) will be replaced by Pto, PZA, PAS or EMB
干预措施: Clofazimine (Drug)
Standard Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ LZD LFX(MFX) CS CFZ regimen for 6 months, then LFX(MFX) CS CFZ for 12 months
- For those resistant to FQs: LFX(MFX) will be replaced by Pto, PZA, PAS or EMB
干预措施: Linezolid (Drug)
Standard Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ LZD LFX(MFX) CS CFZ regimen for 6 months, then LFX(MFX) CS CFZ for 12 months
- For those resistant to FQs: LFX(MFX) will be replaced by Pto, PZA, PAS or EMB
干预措施: Cycloserine (Drug)
Standard Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ LZD LFX(MFX) CS CFZ regimen for 6 months, then LFX(MFX) CS CFZ for 12 months
- For those resistant to FQs: LFX(MFX) will be replaced by Pto, PZA, PAS or EMB
干预措施: Prothionamide (Drug)
Standard Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ LZD LFX(MFX) CS CFZ regimen for 6 months, then LFX(MFX) CS CFZ for 12 months
- For those resistant to FQs: LFX(MFX) will be replaced by Pto, PZA, PAS or EMB
干预措施: Pyrazinamide (Drug)
Standard Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ LZD LFX(MFX) CS CFZ regimen for 6 months, then LFX(MFX) CS CFZ for 12 months
- For those resistant to FQs: LFX(MFX) will be replaced by Pto, PZA, PAS or EMB
干预措施: Para-Aminosalicylic Acid (Drug)
Standard Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
- For those sensitive to FQs: BDQ LZD LFX(MFX) CS CFZ regimen for 6 months, then LFX(MFX) CS CFZ for 12 months
- For those resistant to FQs: LFX(MFX) will be replaced by Pto, PZA, PAS or EMB
干预措施: Ethambutol (Drug)
结局指标
主要结局
Favourable outcome rate at 24 months after randomization
时间窗: from randomization to 24 months after
The proportion of participants with a favourable outcome. A participant's outcome will be classified as favourable if their last two sputum culture results are negative unless they have previously been classified as unfavourable. These two cultures must be taken on separate visits (with ≥28d interval); the latest of which not being earlier than month 23 from randomization.
次要结局
- Unfavourable outcome rate at 24 months after randomization(from randomization to 24 months after)
- Time to culture conversion(from randomization to 24 months after)
- Grade 3 or higher adverse event rate(from randomization to 24 months after)
研究者
Chu naihui
Professor
Beijing Chest Hospital