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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHuashan Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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#;

Trial design

Treatments tested in this trial

  • Short Regimen with Rifapentine 10mg/kg
  • Standardized Regimen
  • Short Regimen with Rifapentine 15mg/kg
  • Short Regimen with Rifapentine 20mg/kg

Treatment groups

2,442 Participants
are divided into 4 treatment groups

Sponsors and collaborators