# Rifapentine- and moxifloxacin-containing short-course regimens for mild spinal tuberculosis: study protocol for a multicenter, randomized, non-inferiority phase II clinical trial

## TL;DR

This study tests if a shorter 6-month treatment with rifapentine and moxifloxacin is as effective as a longer 12-month regimen for mild spinal tuberculosis.

## Contribution

The study introduces a novel short-course regimen with rifapentine and moxifloxacin for mild spinal tuberculosis treatment.

## Key findings

- The trial compares a 6-month regimen to a 12-month regimen for mild spinal tuberculosis.
- It aims to determine if the shorter regimen is non-inferior in preventing recurrence and adverse events.

## Abstract

Spinal tuberculosis is the most common form of osteoarticular infection, with recommended anti-tuberculosis treatment durations typically being long (9–18 months), even for mild cases, increasing the risks of drug resistance, toxicity, and poor patient adherence. This study aims to explore, in patients with mild spinal tuberculosis, whether a new combination of anti-tuberculosis drugs (containing rifapentine and moxifloxacin) could shorten the treatment duration.

This trial is an open-label, randomized, controlled, non-inferiority trial comparing the efficacy and safety of a short-course regimen [6-month anti-TB regimen] containing rifapentine and moxifloxacin with empirical long-course regimen [12-month anti-TB regimen] in the treatment of patients with mild spinal tuberculosis. Patients diagnosed with mild spinal tuberculosis who meet the inclusion and exclusion criteria will be recruited and randomized in a 1:1 ratio to either of the two arms. Empirical long-course regimen includes rifampin, isoniazid, pyrazinamide and ethambutol (2RHZE/10RH), while short-course regimen includes rifapentine, moxifloxacin, isoniazid and pyrazinamide (2HRtZM/4HRtM). The primary outcomes are TB-recurrence rate at 24 months after completion of treatment and proportion of participants with grade 3 or higher adverse events during treatment with study medications.

This trial will provide evidence whether a short-course regimen of anti-TB drugs (2HRtZM/4HRtM) is non-inferior to the empirical long-course regimen (2RHZE/10RH) in patients with mild spinal tuberculosis. If non-inferiority is established, it will contribute to a more optimized treatment for spinal tuberculosis.

This study is registered with https://clinicaltrials.gov/ct2/show/NCT06917495 as NCT06917495.