Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)

PHASE4CompletedINTERVENTIONAL
Enrollment

354

Participants

Timeline

Start Date

June 1, 2020

Primary Completion Date

August 10, 2024

Study Completion Date

August 10, 2024

Conditions
Multidrug Resistant Tuberculosis
Interventions
DRUG

PZA sensitivity guided ultra-short all Oral Regimen

Pyrazinamide 1500 mg daily; Levofloxacin ≤50kg 500 mg daily, \>50kg 750mg daily; Linezolid: 600 mg daily; Cycloserine ≤50kg 500 mg daily, \>50kg 750mg daily; Clofazimine 100 mg daily; All treatment is taken daily;

DRUG

Standardized Shorter Regimen

Pyrazinamide 1500 mg daily;Levofloxacin 400 mg daily,; Prothionamide ≤50kg 500 mg daily, \>50kg 750mg daily; Ethambutol: ≤50kg 750 mg daily, \>50kg 1000mg daily; Clofazimine: 100 mg daily; Amikacin 600mg daily; High-dose isoniazid 600mg daily. All treatment is taken daily.

Trial Locations (13)

200040

Huashan Hospital of Fudan University, Shanghai

Unknown

The Third People's Hospital of Shenzhen City, Shenzhen

Guiyang Public Health Treatment Center, Guizhou

The Sixth People's Hospital of Zhengzhou, Zhengzhou

Hunan Chest Hospital, Changsha

Xuzhou Infectious Disease Hospital, Xuzhou

Shanxi Provincial Tuberculosis Control Institute, Xi’an

Southwest Medical University Affiliated Hospital, Luzhou

Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC, Ürümqi

Hangzhou Red Cross Hospital, Hangzhou

Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou

The Central Hospital of Wenzhou City, Wenzhou

Jiangxi Chest Hospital, Nanchang

All Listed Sponsors
lead

Huashan Hospital

OTHER

NCT03867136 - Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T) | Biotech Hunter | Biotech Hunter