Development of microsatellite markers for Sargentodoxa cuneata (Lardizabalaceae) using next‐generation sequencing technology

Abstract

NCBINCBI Logo Skip to main content Skip to navigation Resources How To About NCBI Accesskeys Sign in to NCBI PubMed US National Library of Medicine National Institutes of Health Search database Search term Clear input Advanced Help Result Filters Abstract Send to: Lancet. 2015 Mar 7;385(9971):875-82. doi: 10.1016/S0140-6736(14)61233-2. Epub 2014 Nov 5. Antibiotic treatment for 6 weeks versus 12 weeks in patients with pyogenic vertebral osteomyelitis: an open-label, non-inferiority, randomised, controlled trial. Bernard L1, Dinh A2, Ghout I3, Simo D3, Zeller V4, Issartel B5, Le Moing V6, Belmatoug N7, Lesprit P8, Bru JP9, Therby A10, Bouhour D11, Dénes E12, Debard A13, Chirouze C14, Fèvre K15, Dupon M16, Aegerter P17, Mulleman D18; Duration of Treatment for Spondylodiscitis (DTS) study group. Collaborators (117) Author information 1Division of Infectious Diseases, University Hospital Bretonneau, Tours, France; Division of Infectious Diseases, Bretonneau University Hospital, Tours, France. Electronic address: lbernard@univ-tours.fr. 2Division of Infectious Diseases, University Hospital Raymond Poincaré, Garches, France. 3Clinical Research Unit, University Hospital Ambroise Paré, Boulogne, France. 4Referral Centre for Bone and Joint Infections, Hospital Diaconesses Croix Saint-Simon, Paris, France. 5Unité Mobile des Référents en Infectiologie, Villeurbanne, France. 6Maladies Infectieuses et Tropicales, University Hospital, Montpellier, France. 7Division of Internal Medicine, University Hospital, Beaujon-Clichy, France. 8Mobile Infectious Diseases Unit, University Hospital, Créteil, France. 9Division of Infectious Diseases, Regional Hospital, Annecy, France. 10Division of Infectious Diseases, General Hospital of Versailles, Le Chesnay, France. 11Division of Infectious Diseases, General Hospital, Bourg en Bresse, France. 12Division of Infectious Diseases, Limoges University Hospital, Limoges, France. 13Division of Infectious Diseases, University Hospital, Toulouse, France. 14Division of Infectious Diseases University Hospital, Besançon, France. 15Division of Infectious Diseases, Bretonneau University Hospital, Tours, France. 16Division of Infectious Diseases, Bordeaux University Hospital, Bordeaux, France. 17Clinical Research Unit, AP-HP, Ambroise Paré University Hospital, Boulogne, France. 18Division of Rheumatology, University Hospitals of Tours, Tours, France. Abstract 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.