ArticlesAntibiotic treatment for 6 weeks versus 12 weeks in patients with pyogenic vertebral osteomyelitis: an open-label, non-inferiority, randomised, controlled trial
Introduction
Pyogenic vertebral osteomyelitis generally occurs as an acute osteomyelitis infection in patients older than 55 years. The estimated incidence of vertebral osteomyelitis is four–ten per 100 000 inhabitants per year in high-income countries,1, 2 and has risen in recent years, increasing the economic burden of the disease.3, 4 The optimum duration of antibiotic treatment is unknown; however, most guidelines regard about 6–12 weeks of treatment as the standard of care,3, 4, 5, 6 although this recommendation is not evidence based.7, 8, 9 Other experts recommend antibiotic treatment for a minimum of 3 months.3, 10, 11 Long-term exposure to antibiotics increases the frequency of adverse events, health-care-related infections, costs, and antibiotic resistance.11, 12, 13 We aimed to compare treatment duration with effective antibiotics for 6 weeks and 12 weeks in patients with microbiologically confirmed pyogenic vertebral osteomyelitis.
Section snippets
Study design and patients
In this multicentre, open-label, non-inferiority, randomised, controlled trial, we enrolled patients with pyogenic vertebral osteomyelitis from 71 medical care centres (infectious diseases, rheumatology, or internal medicine departments) in France. We included patients aged 18 years or older with microbiologically confirmed pyogenic vertebral osteomyelitis and typical radiological features (with MRI or CT scan). Criteria for microbiological identification of the causative agent were isolation
Results
Between Nov 15, 2006, and March 15, 2011, 359 patients underwent randomisation: 182 patients were allocated to the 6-week antibiotic treatment regimen and 177 to the 12-week antibiotic treatment regimen. Most patients (267 [74%]) were randomly assigned on the day after giving consent (appendix). Eight patients were excluded after randomisation (six from the 6-week group and two from the 12-week group; figure).
Table 1 shows the baseline clinical characteristics of the 351 patients included in
Discussion
In this large, prospective, multicentre, randomised clinical trial, our results showed the non-inferiority of a 6-week treatment regimen versus a 12-week regimen for patients with pyogenic vertebral osteomyelitis meeting strict microbiological criteria and receiving appropriate antibiotic treatment. In our study, non-inferiority of the efficacy of 6-week treatment was not shown in some subgroups (age 75 years or older, or patients with immunodepression or diabetes, endocarditis, or neurological
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