Randomized Clinical Trial Determining Proper Duration of Suppressive Antibiotic Therapy After Total Joint Arthroplasty Debridement, Antibiotics, and Implant Retention
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 438
- 试验地点
- 1
- 主要终点
- Reoperation for infection recurrence
研究概览
简要总结
Multiple studies have demonstrated oral suppressive antibiotic therapy (SAT), after intravenous antibiotics, maximizes reoperation-free survival of total joint arthroplasty (TJA) debridement, antibiotics, and implant retention (DAIR) for acute periprosthetic joint infection (PJI). However, little is known regarding sequelae of SAT after DAIR for PJI. Prior studies have small or heterogeneous patient cohorts, variable antibiotic regimens, arrive at disparate conclusions, and do not establish antibiotic resistance risk.
The investigators propose a prospective randomized controlled multicenter study to expand on findings in a retrospective, multi-center pilot study. Study aims are to evaluate SAT after DAIR of acutely infected primary TJA regarding: 1) adverse drug reactions/intolerance; 2) reoperation for infection; and 3) antibiotic resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years-old
- •underwent DAIR with modular component exchange for acute TJA PJI, as defined by Musculoskeletal Infection Society Criteria, with symptom duration less than 4 weeks
- •on postoperative oral SAT for at least 3 months
排除标准
- •underwent aseptic revision surgery
- •had one-stage, 1.5-stage, or two-stage revision surgery
- •did not have postoperative SAT
- •did not have follow-up that allowed for evaluation of SAT sequelae
研究组 & 干预措施
6 months of SAT
TJA DAIR, followed by 6 weeks of IV antibiotics then 6 months of oral suppressive antibiotic therapy
干预措施: 6 months of SAT (Drug)
12 months of SAT
TJA DAIR, followed by 6 weeks of IV antibiotics then 12 months of oral suppressive antibiotic therapy
干预措施: 12 months of SAT (Drug)
Indefinite SAT
TJA DAIR, followed by 6 weeks of IV antibiotics then indefinite oral suppressive antibiotic therapy
干预措施: Indefinite SAT (Drug)
结局指标
主要结局
Reoperation for infection recurrence
时间窗: 2 years after patient enrollment
次要结局
- Antibiotic resistance, evidenced by change in antimicrobial sensitivity profile, developed by infecting organism after suppressive antibiotic therapy causing infection recurrence(At time of reoperation (within 2 years of patient enrollment))
- Adverse drug reaction or intolerance, defined as any symptom or laboratory value derangement requiring a change in, or discontinuation of, antimicrobial therapy(During antibiotic administration (up to 2 years after patient enrollment))
研究者
Sumon Nandi
Associate Professor, Chief of Adult Reconstruction
University of Maryland, Baltimore