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Asymptomatic TB With Innovative Modified Short-course Regimens
Sponsor: Huashan Hospital
Summary
This study is a randomized controlled trial among asymptomatic tuberculosis individuals aiming to assess whether the standard treatment duration can be shortened to 17 weeks without increasing the types or doses of anti-tuberculosis medications or 13 weeks with the high-dose rifapentine and moxifloxacin.
Official title: Clinical Efficacy of a Short-course Regimen for Asymptomatic Tuberculosis in China
Key Details
Gender
All
Age Range
14 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
426
Start Date
2025-11-21
Completion Date
2028-11
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
Four-month regimen
The four-month regimen consists of a 17-week course of standard daily first-line anti-tuberculosis therapy, administered as either fixed-dose combinations or separate bulk drugs, in accordance with the recommendations of Technical Guidelines for Tuberculosis Prevention and Control in China. The treatment comprises an intensive phase of 8 weeks with Isoniazid (H) , Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E), followed by continuation phase of 9 weeks with HR. If the sputum culture remains positive at week 8, or if the radiological examination at the end of treatment still shows unclosed cavities, the continuation phase treatment will be extended by an additional 8 weeks.
Three-month regimen
Three-month regimen consists of two periods of 13-21 weeks. During the intensive phase (8 weeks), rifapentine 900 mg daily; moxifloxacin 400 mg daily; isoniazid 300 mg daily; pyrazinamide \<50.0kg 1000mg daily, 50.0-70.9kg 1500 mg daily, ≥71kg 2000mg daily. During the continuation phase (5 or 13 weeks based on the culture resultes and radiological manifestations), rifapentine 900 mg daily; moxifloxacin 400 mg daily; isoniazid 300 mg daily; All treatment is taken orally. For rifapentine administration, the daily dosage may be reduced to 600mg if intolerance occurs.
Standard regimen
The standardized regimen consists of a 26-week course of standard daily first-line anti-tuberculosis therapy, administered as either fixed-dose combinations or separate bulk drugs, in accordance with the recommendations of Technical Guidelines for Tuberculosis Prevention and Control in China. The treatment comprises an intensive phase of 8 weeks with Isoniazid (H) , Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E), followed by continuation phase of 18 weeks with HR.
Locations (5)
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Liupanshui City Third People's Hospital
Liupanshui, Guizhou, China
Nayong County People's Hospital
Nayong, Guizhou, China
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
The First People's Hospital of Linping District, Hangzhou
Hangzhou, Zhejiang, China