Antibiotic treatment for 6 weeks versus 12 weeks in patients with pyogenic vertebral osteomyelitis: an open-label, non-inferiority, randomised, controlled trial
P : aged 18 years or older with microbiologically confirmed pyogenic vertebral osteomyelitis and typical radiological features from 71 medical care centres across France.
E : 6 weeks ; 176 patients
C : 12 weeks of antibiotic treatment ; 175 patients
O : 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.
T : open-label, non-inferiority, randomised controlled trial
Six-week versus twelve-week antibiotic therapy for nonsurgically treated diabetic foot osteomyelitis: a multicenter open-label controlled randomized study.
P : patients with DFO treated nonsurgically (i.e., antibiotics alone)
E : 6- week duration of antibiotic treatment ; 20patients
C : 12-week duration of antibiotic treatment ; 20patients
O : no significant differences between patients treated for 6 versus 12 weeks (12/20 vs. 14/20, respectively; P = 0.50).
T : prospective randomized trial
Most cases of vertebral osteomyelitis respond to antimicrobial therapy. However, surgery is necessary in some patients.
We recommend, in stable patients, to hold antibiotics until results of blood cultures and needle aspirate are available (Grade 1C).
When the culture and/or Gram stain of the CT-guided needle biopsy is positive, antibiotic therapy should be guided by the results of susceptibility testing. For most patients, we recommend treatment with parenteral antibiotics (Grade 1B).
In patients with negative cultures and Gram stains despite repeat biopsies and in unstable patients, we recommend empiric treatment based on the most likely organisms to cause infection (Grade 1B). An appropriate empiric regimen consists of vancomycin (15 to 20 mg/kg/dose every 8 to 12 hours, not to exceed 2 g per dose) plus one of the following: cefotaxime (2 g intravenously [IV] every six hours), ceftazidime (1 to 2 g IV every eight to 12 hours), ceftriaxone (1 to 2 g IV daily), cefepime (2 g IV every 12 hours), or ciprofloxacin (400 mg IV every 12 hours or 500 to 750 mg orally twice daily).
If treatment in patients in whom empiric therapy is initiated does not result in objective clinical improvement in three to four weeks, we typically request a third percutaneous needle biopsy or an open surgical biopsy be performed.
We routinely treat for a minimum of six weeks. Longer therapy (12 weeks) may be necessary for patients with advanced disease.
Surgery is necessary in a minority of patients with vertebral osteomyelitis.
Lew DP, et al. N Engl J Med. 1997
Osteomyelitis. - PubMed - NCBITREATMENT