Antibiotic treatment for 6 weeks versus 12 weeks in patients with pyogenicvertebral osteomyelitis: an open-label, non-inferiority, randomised, controlledtrial.
2015年 (Epub2014年) Lancetに報告された、フランス71施設における化膿性脊椎炎患者に対する抗菌薬治療6週 vs 12週を比較した、非劣性・非盲検・無作為化比較試験。
- Antibiotic treatment for 6 weeks versus 12 weeks in patients with pyogenicvertebral osteomyelitis: an open-label, non-inferiority, randomised, controlledtrial.
patients aged 18 years or older with microbiologically confirmed pyogenic vertebral osteomyelitis and typical radiological features
E : 6 weeks of antibiotic treatment (physician's choice in accordance with French guidelines)
C : 12 weeks of antibiotic treatment (physician's choice in accordance with French guidelines)
O : the proportion of patientswho were classified as cured at 1 year
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
One limitation of this trial is its open-label design. Nevertheless, the members of the independent adjudication committee were masked to the duration of antibiotic treatment. Since the choice of antibiotics was left to the treating physician, the use of a placebo for each of the drugs prescribed would have raised insurmountable technical and logistical problems. In our study, 92% of patients were given antibiotics with a high oral bioavailability, such as a fluoroquinolone-rifampicin combination or aminopenicillin. We noted no differences in the distribution of antibiotics used between the two groups, irrespective of the microorganism considered. Furthermore, the proportion of patients cured in our study was as much as that in earlier published data.
Another limitation of this study is related to the fact that the duration of intravenous use was not standardised. In a retrospective study, McHenry and colleagues postulated that 4–6 weeks of parenteral therapy was the minimum acceptable duration for a favourable outcome in patients with pyogenic vertebral osteomyelitis. In our study, 52% of patients received intravenous treatment for less than 14 days. We showed no significant difference in the proportion of patients with treatment failure between patients given protracted intravenous treatment (>1 week) and those given intravenous treatment for less than 1 week.