Clinical Efficacy of a Short-course Regimen for Asymptomatic Tuberculosis in China

What this Trial Is About

Researchers are evaluating shorter treatment regimens for people with asymptomatic tuberculosis in this prospective, open-label, multicenter randomized controlled trial. The study aims to determine if reducing the treatment duration to 17 weeks without changing medication types or doses, or to 13 weeks using high-dose rifapentine and moxifloxacin, affects treatment outcomes. The trial uses a centralized randomization method to assign participants evenly across study groups to reduce bias. Participants will be randomly assigned to one of three treatment groups: the standard regimen lasting 26 weeks, the four-month regimen lasting 17 weeks, or the three-month regimen lasting 13 to 21 weeks. The standard regimen includes an intensive 8-week phase with rifampicin, isoniazid, pyrazinamide, and ethambutol, followed by 18 weeks of rifampicin and isoniazid. The four-month group follows the same 8-week intensive phase, then 9 weeks of rifampin and isoniazid, possibly extended by 8 weeks if sputum culture or imaging shows ongoing disease. The three-month group uses high-dose rifapentine, moxifloxacin, isoniazid, and pyrazinamide for 8 weeks, then a continuation phase of rifapentine, moxifloxacin, and isoniazid for 5 or up to 13 weeks based on response. During the study, participants will be monitored for treatment response through sputum cultures and radiological exams. Researchers will assess outcome measures such as favorable treatment rates at 78 weeks, relapse rates at 104 weeks, sputum culture conversion at 8 weeks, and adverse events throughout treatment and follow-up. Quality of life, drug resistance, and community transmission risk will also be evaluated. The total study period for each participant includes treatment and long-term follow-up extending beyond two years post-randomization.

Asymptomatic TB With Innovative Modified Short-course Regimens