Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis:BDLL Chinese Cohort

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 27, 2024

Primary Completion Date

February 28, 2027

Study Completion Date

June 30, 2027

Conditions
Drug-resistant TuberculosisPulmonary TuberculosisRifampin-resistant Tuberculosis
Interventions
DRUG

bedaquiline

400 milligrams (mg) daily for 2 weeks(w), then 200mg three times a week for 22 weeks (w)

DRUG

delamanid

"* for participants weighing up to 33.9 kilograms (kg): 50mg two times a day for 24w~* for participants weighing 34kg or above: 100mg two times a day for 8w, then 200mg daily for 16w"

DRUG

linezolid

"* for participants weighing up to 33.9kg: 450mg daily;~* for participants weighing 34kg or above: 600mg daily; for 24w if a negative culture is obtained from sputum collected at 16w, or else for 36w"

DRUG

Levofloxacin

"Only for participants with confirmed fluoroquinolone-susceptible TB or unknown fluoroquinolone susceptibility:~* for participants weighing up to 33.9kg: 500mg daily~* for participants weighing 34kg to 49.9kg: 750 daily~* for participants weighing 50kg or above: 1000mg daily for 24w if a negative culture is obtained from sputum collected at 16w, or else for 36w"

DRUG

Clofazimine

"Only for participants with confirmed fluoroquinolone-resistant TB or unknown fluoroquinolone susceptibility:~100mg daily, for 24w if a negative culture is obtained from sputum collected at 16w, or else for 36w"

Trial Locations (34)

Unknown

Anhui Chest Hospital, Hefei

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

The First Affiliated Hospital of Xiamen University, Xiamen

The Fourth People's Hospital of Nanning, Nanning

Liupanshui Third People's Hospital, Liupanshui

Hebei Chest Hospital, Shijiazhuang

The Fifth Hospital of Shijiazhuang, Shijiazhuang

Infectious Disease Hospital of Heilongjiang Province, Harbin

Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital), Jiamusi

Harbin Chest Hospital, Harbin

Luoyang Center Hospital, Luoyang

The First Affiliated Hospital of Xinxiang Medical University, Xinxiang

Henan Chest Hospital, Zhengzhou

Henan Infectious Disease Hospital, Zhengzhou

Wuhan Pulmonary Hospital,Wuhan Tuberculosis Prevention and Control Institute, Wuhan

Changsha Central Hospital, Changsha

Hulunbuir Infectious Disease Hospital, Hulunbuir

The Second Hospital of Nanjing, Nanjing

Jiangxi Chest Hospital, Nanchang

Infectious Disease Hospital of Changchun, Changchun

Jilin Tuberculosis Hospital, Jilin

Shenyang Chest Hospital, Shenyang

Xi'an Chest Hospital, Xi'an

Shandong Public Health Clinical Center, Shandong University, Jinan

Linyi People Hospital, Linyi

Qingdao Chest Hospital, Qingdao

Weifang No.2 People's Hospital, Weifang

Yantai Qishan Hospital, Yantai

Shanxi Medical University Affiliated Chest Hospital, Taiyuan

Public Health Clinical Center of Chengdu, Chengdu

Tianjin Haihe Hospital, Tianjin

Wenzhou Central Hospital, Wenzhou

Beijing Chest Hospital, Beijing

Huashan Hospital, Shanghai

All Listed Sponsors
collaborator

Beijing Chest Hospital

OTHER

lead

Huashan Hospital

OTHER