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RECRUITING
NCT05401071
PHASE2/PHASE3

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

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

Summary

Tuberculosis (TB) remains the most important infectious disease in the world. A major barrier to tuberculosis control is poor adherence to long-term and complex treatment regimens. This is a multicenter prospective, non-inferiority randomized controlled study. The purpose of our study is a) to evaluate the tolerability, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of the high-dose rifapentine, b) to evaluate whether the high-dose rifapentine-containing regimen has the potential to treat the rifampicin-sensitive pulmonary tuberculosis and shorten the course of treatment to 17 weeks. This study is of great significance for shortening the course of treatment, reducing the adverse reactions and economic burden of patients' treatment in rifampicin-sensitive tuberculosis patient.

Official title: Efficacy and Safety of Short-course Treatment for Drug-sensitive Tuberculosis in China

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

2442

Start Date

2023-01-13

Completion Date

2027-11-01

Last Updated

2023-12-11

Healthy Volunteers

No

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.

Locations (6)

Guiyang Public Health Clinical Center

Guiyang, Guizhou, China

People's Hospital of Qiandongnan

Kaili, Guizhou, China

The Third People's Hospital of Liupanshui

Liupanshui, Guizhou, China

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Department of Infectious Disease, Huashan Hospital

Shanghai, Shanghai Municipality, China

People's Hospital of Zhuji, Zhejiang Province

Zhuji, Zhejiang, China