Antibiotic treatment for 6 weeks versus 12 weeks in patients with pyogenic vertebral osteomyelitis: an open-label, non-inferiority, randomised, controlled trial.

BACKGROUND: Duration of treatment for patients with vertebral osteomyelitis is mainly based on expert recommendation rather than evidence. We aimed to establish whether 6 weeks of antibiotic treatment is non-inferior to 12 weeks in patients with pyogenic vertebral osteomyelitis. METHODS: In this open-label, non-inferiority, randomised controlled trial, we enrolled patients aged 18 years or older with microbiologically confirmed pyogenic vertebral osteomyelitis and typical radiological features from 71 medical care centres across France. Patients were randomly assigned to either 6 weeks or 12 weeks of antibiotic treatment (physician's choice in accordance with French guidelines) by a computer-generated randomisation list of permuted blocks, stratified by centre. The primary endpoint was the proportion of patients who were classified as cured at 1 year by a masked independent validation committee, analysed by intention to treat. Non-inferiority would be declared if the proportion of cured patients assigned to 6 weeks of treatment was not less than the proportion of cured patients assigned to 12 weeks of treatment, within statistical variability, by an absolute margin of 10%. This trial is registered with EudraCT, number 2006-000951-18, and Clinical Trials.gov, number NCT00764114. FINDINGS: Between Nov 15, 2006, and March 15, 2011, 359 patients were randomly assigned, of whom six in the 6-week group and two in the 12-week group were excluded after randomisation. 176 patients assigned to the 6-week treatment regimen and 175 to the 12-week treatment regimen were analysed by intention to treat. 160 (90·9%) of 176 patients in the 6-week group and 159 (90·9%) of 175 of those in the 12-week group met the criteria for clinical cure. The difference between the groups (0·05%, 95% CI -6·2 to 6·3) showed the non-inferiority of the 6-week regimen when compared with the 12-week regimen. 50 patients in the 6-week group and 51 in the 12-week group had adverse events, the most common being death (14 [8%] in the 6-week group vs 12 [7%] in the 12-week group), antibiotic intolerance (12 [7%] vs 9 [5%]), cardiorespiratory failure (7 [4%] vs 12 [7%]), and neurological complications (7 [4%] vs 3 [2%]). INTERPRETATION: 6 weeks of antibiotic treatment is not inferior to 12 weeks of antibiotic treatment with respect to the proportion of patients with pyogenic vertebral osteomyelitis cured at 1 year, which suggests that the standard antibiotic treatment duration for patients with this disease could be reduced to 6 weeks. FUNDING: French Ministry of Health.

Case-control study of lymphoid neoplasm in three French areas: description, alcohol and tobacco consumption.

A multi-centre hospital-based case-control study was conducted in three regions of France between 2000 and 2003 in order to establish the risk factors of lymphoid neoplasms. We report here results concerning alcohol and tobacco consumption. A total of 298 cases and 276 controls, case-matched by inclusion centre, age and sex were included. Cases were classified according to the World Health Organization classification and validated by an expert panel of eight pathologists. Overall alcohol intake did not incur any risk increase for non-Hodgkin's lymphoma. Wine consumption marginally increased the risk of follicular lymphoma [odds ratio=2.19 (0.83-5.80)], with a higher risk for drinkers who started before the age of 20 years [odds ratio=4.04 (1.19-13.76)] and for drinkers who consumed more than 19 g of alcohol per day [odds ratio=4.37 (1.04-18.45)]. Beer and spirit consumption was not linked to non-Hodgkin's lymphoma risk. Tobacco consumption did not show a risk increase. The risk increase of follicular lymphoma due to wine consumption was new. We discuss this risk based on the French context, France being the European country with the highest alcohol consumption, particularly of wine.