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.
Age between 18 to 60 years;
Weight between 40 to 80 kg;
Individuals with smear-positive pulmonary tuberculosis and sensitive to rifampicin ;
Willing to provide signed informed consent, or parental consent and participant assent.
Combined extrapulmonary tuberculosis;
Patients with extensive lesion (extent of disease greater than 50% or cavity size greater than 4cm) ;
Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones;
Alcohol abuse#drinking more than 64g of ethanol a day for male, 42g for female#;
Parallel
Short Regimen with Rifapentine 10mg/kg
Other interventionrifapentine 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.
Standardized Regimen
Combination productDuring 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.
Short Regimen with Rifapentine 15mg/kg
Other interventionrifapentine 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.
Short Regimen with Rifapentine 20mg/kg
Other interventionrifapentine 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.
Treatment success rate of the short regimen during drug treatment and follow-up.
To compare the treatment success rate without relapse between the short regimen with rifapentine 10mg/kg, the short regimen with rifapentine 15mg/kg, the short regimen with rifapentine 20mg/kg and the WHO standardized regimen group.
The frequency of grade 3 or greater adverse events among patients Over the 108 Week Treatment and Follow-up Period.
To compare the proportion of patients who experience grade 3 or greater adverse events between the short regimen with rifapentine 10mg/kg, the short regimen with rifapentine 15mg/kg, the short regimen with rifapentine 20mg/kg and the WHO standardized regimen group.
Relapse rate during follow-up.
To compare the treatment success rate without relapse between the short regimen with rifapentine 10mg/kg, the short regimen with rifapentine 15mg/kg, the short regimen with rifapentine 20mg/kg and the WHO standardized regimen group.
the percentage of participants found to be culture-negative at the end of intensive phase and the end of treatment phase
To compare the percentage of participants found to be culture-negative at the end of intensive phase and the end of treatment phase between the short regimen with rifapentine 10mg/kg, the short regimen with rifapentine 15mg/kg, the short regimen with rifapentine 20mg/kg and the WHO standardized regimen group.
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