drugset / Trial / NCT06917495

Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis

NCT06917495 ↗

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

EvaluationDrugModalityDoseRoute
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 Rifampicin 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 —

Indications