Rifapentine- and moxifloxacin-containing short-course regimens for mild spinal tuberculosis: study protocol for a multicenter, randomized, non-inferiority phase II clinical trial
Abstract
Background 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. Methods and Analysis 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. Discussion This trial will provide evidence whether a short-course regimen of anti-TB drugs…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Structural and topological analysis of thiosemicarbazone-based metal complexes: computational and experimental study of bacterial biofilm inhibition and antioxidant activity
- Toward better cures for Mycobacterium abscessus lung disease
- Challenges for global antibiotic regimen planning and establishing antimicrobial resistance targets: implications for the WHO Essential Medicines List and AWaRe antibiotic book dosing
- Design, Synthesis and In vitro Antitubercular Effect of New Chalcone Derivatives Coupled with 1,2,3‐Triazoles: A Computational Docking Techniques
- Upregulation of pmrA, pmrB, pmrC, phoQ, phoP, and arnT genes contributing to resistance to colistin in superbug Klebsiella pneumoniae isolates from human clinical samples in Tehran, Iran
- Whole-genome sequencing of clinical isolates of Citrobacter Europaeus in China carrying blaOXA−48 and blaNDM−1
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.