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 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

Indications