Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

2,442

Participants

Timeline

Start Date

January 13, 2023

Primary Completion Date

October 1, 2024

Study Completion Date

November 1, 2027

Conditions
Tuberculosis, Pulmonary
Interventions
OTHER

Short Regimen with Rifapentine 10mg/kg

rifapentine 10mg/kg daily; isoniazid 300mg daily; pyrazinamide ≤50kg 1000mg daily, 50-71kg 1200mg daily, \>71kg 1000mg daily; moxifloxacin 400mg daily. All treatment is taken orally.

COMBINATION_PRODUCT

Standardized Regimen

"During the intensive phase, rifampicin ≤55kg 450mg daily, 55-71kg 600mg daily, \>71kg 750mg daily; isoniazid ≤55kg 225mg daily, 55-71kg 300mg daily, \>71kg 375mg daily; pyrazinamide ≤55kg 900mg daily, 55-71kg 1200mg daily, \>71kg 1600mg daily; ethambutol ≤55kg 825mg daily, 55-71kg 1100mg daily, \>71kg 1375mg daily; All treatment is taken orally.~During the continuation phase, rifampicin ≤50kg 450mg daily, \>50kg 600mg daily; isoniazid 300mg daily; All treatment is taken orally."

OTHER

Short Regimen with Rifapentine 15mg/kg

rifapentine 15mg/kg daily; isoniazid 300mg daily; pyrazinamide ≤50kg 1000mg daily, 50-71kg 1200mg daily, \>71kg 1000mg daily; moxifloxacin 400mg daily. All treatment is taken orally.

OTHER

Short Regimen with Rifapentine 20mg/kg

rifapentine 20mg/kg daily; isoniazid 300mg daily; pyrazinamide ≤50kg 1000mg daily, 50-71kg 1200mg daily, \>71kg 1000mg daily; moxifloxacin 400mg daily. All treatment is taken orally.

Trial Locations (6)

200040

RECRUITING

Department of Infectious Disease, Huashan Hospital, Shanghai

311899

NOT_YET_RECRUITING

People's Hospital of Zhuji, Zhejiang Province, Zhuji

Unknown

NOT_YET_RECRUITING

Guiyang Public Health Clinical Center, Guiyang

NOT_YET_RECRUITING

People's Hospital of Qiandongnan, Kaili

NOT_YET_RECRUITING

The Third People's Hospital of Liupanshui, Liupanshui

NOT_YET_RECRUITING

Affiliated Hospital of Zunyi Medical University, Zunyi

All Listed Sponsors
lead

Huashan Hospital

OTHER