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Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis
Sponsor: Shandong University
Summary
To evaluate the non-inferiority in efficacy between the rifapentine- and moxifloxacin-containing short-course regimens (with rifampicin replaced by rifapentine and ethambutol replaced by moxifloxacin, while isoniazid and pyrazinamide remaining the same as the empirical regimen) and the empirical long-course regimen, so as to determine whether it is possible to shorten the treatment duration to 26 weeks for patients with mild spinal tuberculosis.
Official title: Rifapentine- And Moxifloxacin-Containing Short-Course Regimens for Mild Spinal Tuberculosis: A Multicenter, Randomized, Non-inferiority Clinical Trial
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-04-05
Completion Date
2029-12-31
Last Updated
2025-04-08
Healthy Volunteers
No
Conditions
Interventions
Rifampin
Rifampin: once daily, 600 mg.
Isoniazid
Isoniazid: once daily, 300 mg.
Rifapentine (RPT)
Rifapentine: once daily with dosage adjusted based on body weight: 750 mg for ≤41.2 kg, 900 mg for \>41.3-48.7 kg, 1050 mg for \> 48.8-56.2 kg, 1200 mg for ≥ 56.3 kg.
Moxifloxacin
Moxifloxacin: once daily, 400 mg.
Pyrazinamide
Pyrazinamide: once daily with dosage adjusted based on body weight: 1000 mg for \< 55 kg, 1500 mg for ≥ 55-75 kg, and 2000 mg for \>75 kg.
Ethambutol
Ethambutol: once daily with dosage adjusted based on body weight: 800 mg for \< 55 kg, 1200 mg for ≥ 55-75 kg, and 1600 mg for \> 75 kg.
Locations (1)
Shandong Public Health Clinical Center
Jinan, China