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ACTIVE NOT RECRUITING
NCT06081361
PHASE3

Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis:Contezolid, Delamanid and Bedaquiline Cohort

Sponsor: Beijing Chest Hospital

View on ClinicalTrials.gov

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

DRUG

Bedaquiline

Oral, 400mg qd for 2 weeks, then 200 mg 3 times per week

DRUG

Delamanid

Oral, 100mg bid

DRUG

Contezolid

Oral, 800mg bid

DRUG

Levofloxacin

Oral, 400mg qd for weight \<50kg, 600-750mg qd for weight ≥50kg

DRUG

Moxifloxacin

Oral, 400mg qd

DRUG

Clofazimine

Oral, 100mg qd

DRUG

Linezolid

Oral, 600mg qd

DRUG

Cycloserine

Oral, 250mg bid

DRUG

Prothionamide

Oral, 600mg qd for weight \<50kg, 600-800mg qd for weight ≥50kg

DRUG

Pyrazinamide

Oral, 1500mg qd for weight \<50kg, 1750mg qd for weight ≥50kg

DRUG

Para-Aminosalicylic Acid

8000mg qd for weight \<50kg, 10000mg qd for weight ≥50kg

DRUG

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