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.
This study is a prospective, open-label, multicenter randomized controlled trial. The randomization process will use centralized stratified block randomization to minimize bias across province of participating sites. Asymptomatic tuberculosis individuals included in the study will be randomly assigned in a 1:1:1 ratio to three groups: Standard Regimen Group, Four-month Regimen Group or Three-month Regimen Group. The standard regimen consists of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E) for 8 weeks, followed by rifampicin and isoniazid for an additional 18 weeks. The four-month regimen group follows the same regimen as the standard regimen group for the initial 8 weeks, followed by a continuation phase of daily rifampin (R) and isoniazid (H) for 9 weeks. The three-month regimen consists of high-dose rifapentine (P), isoniazid (H), pyrazinamide (Z), and moxifloxacin (M) for 8 weeks, followed high-dose Rifapentine (P), isoniazid (H), and moxifloxacin (M) for 5 weeks. For individuals in the four-month and the three-month regimen group, the treatment response will be evaluated at the end of the treatment phase. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
426
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 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.
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGLiupanshui City Third People's Hospital
Liupanshui, Guizhou, China
RECRUITINGNayong County People's Hospital
Nayong, Guizhou, China
Favorable outcome rate in mITT pupulation
To compare the proportion of participants in mITT population achieving favorable outcome at 78 weeks post-randomization.
Time frame: At 78 weeks post-randomization
Favorable outcome rate in assessable and PP population
To compare the proportion of participants in assessable population and PP population achieving favorable outcomes at 78 weeks post-randomization.
Time frame: At 78 weeks post-randomization
Relapse rate post-treatment
To compare the proportion of relapse rate post-treatment.
Time frame: At 104 weeks post-randomization
The proportion of participants with sputum culture conversion
The proportion of participants with sputum culture conversion at 8 weeks post-randomization
Time frame: At 8 weeks post-randomization
The proportion of grade 3 or greater adverse events
To evaluate the proportion of participants who experience grade 3 or greater adverse events.
Time frame: From treatment initiation until two weeks after the last dose
Acquired drug resistance
The proportion of participants acquiring drug resistance during follow-up.
Time frame: Post-treatment follow-up phase
Acceptability to regimens
The total score of acceptability in mITT population and PP population at the end of treatment.
Time frame: At the end of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
ACTIVE_NOT_RECRUITINGThe First People's Hospital of Linping District, Hangzhou
Hangzhou, Zhejiang, China
RECRUITINGThe overall index score of quality of life
The overall index score of quality of life in mITT population and PP population at the end of treatment and at 78 weeks post-randomization.
Time frame: At the end of treatment and at 78 weeks post-randomization
Community transmission risk
The community transmission risk in mITT and PP population.
Time frame: From treatment initiation
Serious adverse events
Proportion of serious adverse events from the date of informed consent until completion of the final follow-up.
Time frame: From informed consent through final follow-up