Medical School, University of Western Australia, Harry Perkins Research Institute, Fiona Stanley Hospital, Murdoch, Western Australia; Department of Infectious Diseases, Fiona Stanley Hospital, Perth, Western Australia; Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.
Department of Infectious Diseases, Christchurch Hospital, New Zealand.
Int J Antimicrob Agents. 2022 Jul;60(1):106598. doi: 10.1016/j.ijantimicag.2022.106598. Epub 2022 May 6.
Peri-prosthetic joint infection (PJI) is a devastating complication of joint replacement surgery. Determining the optimal duration of intravenous (IV) antibiotics for PJI managed with debridement and implant retention (DAIR) is a research priority.
Patients undergoing DAIR for early and late-acute PJI of the hip or knee were randomised to receive 2 (short-course) or 6 (standard-course) weeks of IV antibiotics, with both groups completing 12 weeks of antibiotics in total. The primary endpoint of this pilot, open-label, randomised trial was a 7-point ordinal desirability of outcome ranking (DOOR) score, which accounted for mortality, clinical cure and treatment adverse events at 12 months. Duration of IV treatment was used as a tiebreaker, with shorter courses ranked higher. Outcome adjudication was performed by expert clinicians blinded to the allocated intervention (Australia and New Zealand Clinical Trials Registry ACTRN12617000127303).
60 patients were recruited; 31 and 29 were allocated to short- and standard-course treatment, respectively. All had an evaluable outcome at 12 months and were analysed by intention-to-treat. Clinical cure was demonstrated in 44 (73%) overall; 22 (71%) in the short-course group and 22 (76%) in the standard-care group (P=0.77). Using the DOOR approach, the probability that short- was better than standard-course treatment was 59.7% (95% confidence interval 45.1-74.3).
In selected patients with early and late-acute PJI managed with DAIR, shorter courses of IV antibiotics may be appropriate. Due to small sample size, these data accord with, but do not confirm, results from other international trials of early transition to oral antibiotics.
人工关节周围感染(PJI)是关节置换术后一种破坏性的并发症。确定保留假体清创术(DAIR)治疗的 PJI 最佳静脉(IV)抗生素持续时间是研究重点。
接受 DAIR 治疗髋部或膝部早期和晚期急性 PJI 的患者被随机分为接受 2 周(短疗程)或 6 周(标准疗程)的 IV 抗生素治疗,两组总共完成 12 周的抗生素治疗。本试验为开放标签、随机试验的主要终点是 7 点等级愿望结局评分(DOOR),该评分考虑了 12 个月时的死亡率、临床治愈率和治疗不良事件。IV 治疗持续时间作为平局的决胜因素,疗程越短排名越高。结果判断由不了解分配干预措施的专家临床医生进行盲法评估(澳大利亚和新西兰临床试验注册处 ACTRN12617000127303)。
共招募了 60 名患者;31 名和 29 名分别分配到短疗程和标准疗程治疗组。所有患者在 12 个月时均有可评估的结局,并进行了意向治疗分析。总的临床治愈率为 44 例(73%);短疗程组 22 例(71%),标准疗程组 22 例(76%)(P=0.77)。使用 DOOR 方法,短疗程优于标准疗程的概率为 59.7%(95%置信区间 45.1-74.3)。
在接受 DAIR 治疗的早期和晚期急性 PJI 的选定患者中,较短的 IV 抗生素疗程可能是合适的。由于样本量小,这些数据与其他国际早期转换为口服抗生素的试验结果一致,但不能确认。