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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

186

Participants

Timeline

Start Date

December 22, 2023

Primary Completion Date

October 1, 2026

Study Completion Date

December 31, 2026

Conditions
Pulmonary TuberculosisRifampicin-resistant Tuberculosis
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

Trial Locations (39)

101149

Beijing Chest Hospital affiliated to Capital Medical University, Beijing

150000

Harbin Chest Hospital, Harbin

266000

Qingdao Chest Hospital, Qingdao

Unknown

Changsha Central Hospital, Changsha

Anhui Chest Hospital, Hefei

Jiamusi Tumor Hospital, Jiamusi

Shandong public health clinical center, Shandong

Xi'an Chest Hospital, Xi'an

The First Affiliated Hospital of Xinxiang Medical University, Xinxiang

Infectious Disease Hospital of Hulunbuir, Hulunbuir

The 8th Medical Center of Chinese Pla General Hospital, Beijing

Hunan Province Chest Hospital, Changsha

Chongqing Public Heath Treatment Center, Chongqing

Dalian Public Health Center, Dalian

Fuzhou Pulmonary Hospital of Fujian, Fuzhou

Guangzhou Chest Hospital, Guangzhou

Heilongjiang Province center for tuberculosis Control and Prevention, Haerbin

Second Affiliated Hospital of Hainan Medical University, Haikou

Hangzhou Red Cross Hospital, Hangzhou

Second People's Hospital of Hohhot, Hohhot

Jiamusi Infectious Disease Hospital, Jiamusi

Jilin Tuberculosis Hospital, Jilin

People's Hospital of Linyi, Linyi

Second Hospital of Nanjing, Nanjing

Fourth People's Hospital of Nanning, Nanning

Guangxi Chest Hospital, Nanning

National Medical Center for Infectious Disease, Shanghai

Affiliated Hospital of Shaoxing University, Shaoxing

Shenyang Chest Hospital, Shenyang

Shijiazhuang Fifth Hospital, Shijiazhuang

Tianjin Haihe Hospital, Tianjin

The 8th Affiliated Hospital of Xinjiang Medical University, Ürümqi

Second People's Hospital of Weifang, Weifang

Wuhan Institute For Tuberculosis Control, Wuhan

First Affiliated Hospital of Xiamen Medical University, Xiamen

Henan Provincial Chest Hospital, Zhengzhou

Affiliated Hospital of Zunyi Medical University, Zunyi

050000

Hebei Chest Hospital, Shijiazhuang

030000

Taiyuan Fourth People's Hospital, Taiyuan

All Listed Sponsors
collaborator

National Medical Center for Infectious Diseases

UNKNOWN

lead

Beijing Chest Hospital

OTHER

NCT06081361 - Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis:Contezolid, Delamanid and Bedaquiline Cohort | Biotech Hunter | Biotech Hunter