RecruitingPhase 4NCT06153069

Asymptomatic TB With Innovative Modified Short-course Regimens

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


Sponsor

Huashan Hospital

Enrollment

426 participants

Start Date

Nov 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 14 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This randomized trial tests whether tuberculosis treatment for people who test positive but have no symptoms can be shortened from the standard 26 weeks to either 17 or 13 weeks, with the shorter option using higher doses of specific antibiotics. All three treatment arms use standard first-line TB drugs, with the shorter regimens relying on adjustments in duration or drug strength rather than entirely new medications. Eligible participants are 14–80 years old with a confirmed positive TB test result, no TB symptoms in the past three months, and no drug-resistant TB. Participation involves taking daily oral medications for the assigned duration, regular sputum tests, and follow-up visits to check for treatment success and side effects. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFour-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.

DRUGThree-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.

DRUGStandard 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

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NCT06153069


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