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Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis:Contezolid, Delamanid and Bedaquiline Cohort
Sponsor: Beijing Chest Hospital
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
186
Start Date
2023-12-22
Completion Date
2026-12-31
Last Updated
2025-04-01
Healthy Volunteers
No
Interventions
Bedaquiline
Oral, 400mg qd for 2 weeks, then 200 mg 3 times per week
Delamanid
Oral, 100mg bid
Contezolid
Oral, 800mg bid
Levofloxacin
Oral, 400mg qd for weight \<50kg, 600-750mg qd for weight ≥50kg
Moxifloxacin
Oral, 400mg qd
Clofazimine
Oral, 100mg qd
Linezolid
Oral, 600mg qd
Cycloserine
Oral, 250mg bid
Prothionamide
Oral, 600mg qd for weight \<50kg, 600-800mg qd for weight ≥50kg
Pyrazinamide
Oral, 1500mg qd for weight \<50kg, 1750mg qd for weight ≥50kg
Para-Aminosalicylic Acid
8000mg qd for weight \<50kg, 10000mg qd for weight ≥50kg
Ethambutol
750mg qd for weight \<50kg, 1000mg qd for weight ≥50kg
Locations (39)
Beijing Chest Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Changsha Central Hospital
Changsha, China, China
Anhui Chest Hospital
Hefei, China, China
Jiamusi Tumor Hospital
Jiamusi, China, China
Shandong public health clinical center
Shandong, China, China
Xi'an Chest Hospital
Xi'an, China, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China, China
Hebei Chest Hospital
Shijiazhuang, Hebei, China
Harbin Chest Hospital
Harbin, Heilongjiang, China
Infectious Disease Hospital of Hulunbuir
Hulunbuir, Inner Mongolia, China
Qingdao Chest Hospital
Qingdao, Shandong, China
Taiyuan Fourth People's Hospital
Taiyuan, Shanxi, China
The 8th Medical Center of Chinese Pla General Hospital
Beijing, China
Hunan Province Chest Hospital
Changsha, China
Chongqing Public Heath Treatment Center
Chongqing, China
Dalian Public Health Center
Dalian, China
Fuzhou Pulmonary Hospital of Fujian
Fuzhou, 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
Hangzhou Red Cross Hospital
Hangzhou, China
Second People's Hospital of Hohhot
Hohhot, China
Jiamusi Infectious Disease Hospital
Jiamusi, China
Jilin Tuberculosis Hospital
Jilin, China
People's Hospital of Linyi
Linyi, China
Second Hospital of Nanjing
Nanjing, China
Fourth People's Hospital of Nanning
Nanning, China
Guangxi Chest Hospital
Nanning, China
National Medical Center for Infectious Disease
Shanghai, China
Affiliated Hospital of Shaoxing University
Shaoxing, China
Shenyang Chest Hospital
Shenyang, China
Shijiazhuang Fifth Hospital
Shijiazhuang, China
Tianjin Haihe Hospital
Tianjin, China
The 8th Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
Second People's Hospital of Weifang
Weifang, China
Wuhan Institute For Tuberculosis Control
Wuhan, China
First Affiliated Hospital of Xiamen Medical University
Xiamen, China
Henan Provincial Chest Hospital
Zhengzhou, China
Affiliated Hospital of Zunyi Medical University
Zunyi, China