drugset / Trial / NCT06917495
Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis
Phase 2
Not yet recruiting
300 enrolled
Shandong University
Shandong Public Health Clinical Center · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-04-05
- Primary completion
- 2027-12-31
- Completion
- 2029-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ethambutol | Small molecule | 800 mg | — |
| Comparator | Ethambutol | Small molecule | 1200 mg | — |
| Comparator | Ethambutol | Small molecule | 1600 mg | — |
| Subject | Moxifloxacin | Small molecule | 400 mg | — |
| Comparator | Rifampin | Small molecule | 600 mg | — |
| Subject | Rifapentine | Small molecule | 750 mg | — |
| Subject | Rifapentine | Small molecule | 900 mg | — |
| Subject | Rifapentine | Small molecule | 1050 mg | — |
| Subject | Rifapentine | Small molecule | 1200 mg | — |
| Background | Isoniazid | Small molecule | 300 mg | — |
| Background | Pyrazinamide | Small molecule | 1000 mg | — |
| Background | Pyrazinamide | Small molecule | 1500 mg | — |
| Background | Pyrazinamide | Small molecule | 2000 mg | — |