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NOT YET RECRUITING
NCT06917495
PHASE2

Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis

Sponsor: Shandong University

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Shandong Public Health Clinical Center

Jinan, China