Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort
- Conditions
- Pulmonary TuberculosisRifampicin-resistant Tuberculosis
- Interventions
- Registration Number
- NCT06081361
- Lead Sponsor
- Beijing Chest Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 186
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Short-Term Regimen Contezolid 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 Short-Term Regimen Levofloxacin 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 Short-Term Regimen Moxifloxacin 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 Short-Term Regimen Clofazimine 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 Standard Regimen Ethambutol 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 Short-Term Regimen Bedaquiline 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 Short-Term Regimen Delamanid 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 Standard Regimen Bedaquiline 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 Standard Regimen Levofloxacin 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 Standard Regimen Moxifloxacin 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 Standard Regimen Clofazimine 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 Standard Regimen Linezolid 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 Standard Regimen Cycloserine 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 Standard Regimen Prothionamide 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 Standard Regimen Pyrazinamide 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 Standard Regimen Para-Aminosalicylic Acid 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
- Primary Outcome Measures
Name Time Method Favourable outcome rate at 24 months after randomization 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.
- Secondary Outcome Measures
Name Time Method Unfavourable outcome rate at 24 months after randomization from randomization to 24 months after Including
1. Death;
2. Treatment failure
3. Lost-to-follow-up
4. Treatment Discontinuation
5. Ttreatment prolonging
6. Still on treatment at the end of follow up
7. RecurrenceTime to culture conversion from randomization to 24 months after Time from treatment initiation to first negative result in sputum culture confirmed by two consecutive cultures with an interval of ≥28d
Grade 3 or higher adverse event rate from randomization to 24 months after Proportion of participants experiencing at least one grade 3 or higher adverse event, or serious adverse event defined by the Division of AIDS severity criteria for adverse events
Trial Locations
- Locations (39)
Fuzhou Pulmonary Hospital of Fujian
🇨🇳Fuzhou, China
People's Hospital of Linyi
🇨🇳Linyi, China
Fourth People's Hospital of Nanning
🇨🇳Nanning, China
Guangzhou Chest Hospital
🇨🇳Guangzhou, China
Heilongjiang Province center for tuberculosis Control and Prevention
🇨🇳Haerbin, China
Second Affiliated Hospital of Hainan Medical University
🇨🇳Haikou, China
Guangxi Chest Hospital
🇨🇳Nanning, China
Hangzhou Red Cross Hospital
🇨🇳Hangzhou, China
Second People's Hospital of Hohhot
🇨🇳Hohhot, China
Jiamusi Infectious Disease Hospital
🇨🇳Jiamusi, China
Shandong public health clinical center
🇨🇳Shandong, China
Jiamusi Tumor Hospital
🇨🇳Jiamusi, China
Shenyang Chest Hospital
🇨🇳Shenyang, China
Jilin Tuberculosis Hospital
🇨🇳Jilin, China
Second Hospital of Nanjing
🇨🇳Nanjing, China
Xi'an Chest Hospital
🇨🇳Xi'an, China
National Medical Center for Infectious Disease
🇨🇳Shanghai, China
Affiliated Hospital of Shaoxing University
🇨🇳Shaoxing, China
Henan Provincial Chest Hospital
🇨🇳Zhengzhou, China
Shijiazhuang Fifth Hospital
🇨🇳Shijiazhuang, China
Tianjin Haihe Hospital
🇨🇳Tianjin, China
Second People's Hospital of Weifang
🇨🇳Weifang, China
Wuhan Institute For Tuberculosis Control
🇨🇳Wuhan, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, China
First Affiliated Hospital of Xiamen Medical University
🇨🇳Xiamen, China
Affiliated Hospital of Zunyi Medical University
🇨🇳Zunyi, China
The 8th Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, China
Hebei Chest Hospital
🇨🇳Shijiazhuang, Hebei, China
Qingdao Chest Hospital
🇨🇳Qingdao, Shandong, China
Chongqing Public Heath Treatment Center
🇨🇳Chongqing, China
Dalian Public Health Center
🇨🇳Dalian, China
Anhui Chest Hospital
🇨🇳Hefei, China
Harbin Chest Hospital
🇨🇳Harbin, Heilongjiang, China
Taiyuan Fourth People's Hospital
🇨🇳Taiyuan, Shanxi, China
Changsha Central Hospital
🇨🇳Changsha, China
Beijing Chest Hospital affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
Hunan Province Chest Hospital
🇨🇳Changsha, China
Infectious Disease Hospital of Hulunbuir
🇨🇳Hulunbuir, Inner Mongolia, China
The 8th Medical Center of Chinese Pla General Hospital
🇨🇳Beijing, China