NCT06917495

Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis

Rifapentine- And Moxifloxacin-Containing Short-Course Regimens for Mild Spinal Tuberculosis: A Multicenter, Randomized, Non-inferiority Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Spinal Tuberculosis

Interventions

Type	Name	Description
DRUG	Rifampin	Rifampin: once daily, 600 mg.
DRUG	Isoniazid	Isoniazid: once daily, 300 mg.
DRUG	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.
DRUG	Moxifloxacin	Moxifloxacin: once daily, 400 mg.
DRUG	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.
DRUG	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.

Timeline

• Start date: 2025-04-05
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2025-04-08
• Last updated: 2025-04-08

Locations

1 site across 1 country: China