The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB

PHASE4CompletedINTERVENTIONAL
Enrollment

515

Participants

Timeline

Start Date

March 8, 2019

Primary Completion Date

June 8, 2022

Study Completion Date

June 8, 2022

Conditions
Multi-drug Resistant Tuberculosis
Interventions
DRUG

18-month regimen containing 6 anti-TB drugs

Investigational regimen:3Am-Mfx-PZA-X-Y-Z/3Am3-Mfx-PZA-X-Y-Z/12 Mfx-PZA-X-Y-Z.X、Y、Z are the drugs susceptible or possibly susceptible to mycobacterial bacilli(The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid).The abbreviation of the name of each drug in the regimen is explained as follows: PZA-pyrazinamide,Am-Amikacin,Mfx-moxifloxacin)and the total duration of the regimen is 18 months

Trial Locations (20)

Unknown

Beijing Chest Hospital, Beijing

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

Changchun Infectious Disease Hospital, Changchun

Hunan Institute For Tuberculosis Control, Changsha

Public Health Clinical Center of Chengdu, Chengdu

Shenzhen Third Peple's Hospital, Guangzhou

Guangzhou Chest Hospital, Guanzhou

The Affiliated Hospital of Guizhou Medical University, Guiyang

Infectious Disease Prevention Hospital in Heilongjiang Province, Harbin

Anhui Chest Hospital, Hefei

The Fourth People's Hospital of Inner Mongolia Autonomous region, Hohhot

Shandong Provincial Chest Hospital, Jinan

Shanghai Pulmonary Hospital, Shanghai

Shenyang Chest Hospital, Shenyang

Tianjin Haihe Hospital, Tianjin

Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC, Ürümqi

The Tuberculosis Prevention and Treatment Hospital of Shanxi Province, Xi'an

Xi'an Chest Hospital, Xi'an

The Fourth People's Hospital of Ningxia Autonomous Region, Yinchuan

The Infectious Disease Hospital of Wangkai Zaozhuang, Zaozhuang

All Listed Sponsors
lead

Beijing Chest Hospital

OTHER

NCT03830671 - The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB | Biotech Hunter | Biotech Hunter