Oral vs Intravenous Antibiotics for Treatment of Periprosthetic Joint Infection
试验速览
- 阶段
- 3 期
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Rate of Postoperative Infections
研究概览
简要总结
Management of periprosthetic joint infection (PJI) commonly includes 6 weeks of intravenous (IV) antibiotics after surgical treatment. However, there is little evidence to suggest that oral (PO) therapy results in worse outcomes. This study aims to determine whether or not PO antibiotics are non-inferior to IV antibiotics in treating PJI. The study is a multicenter, parallel-group, randomized (1 : 1), open-label, non-inferiority trial. The non-inferiority margin will be set at 10%. Adults with a clinical diagnosis of PJI according to the International Consensus Meeting (ICM) criteria who would ordinarily receive at least 6 weeks of antibiotics and have received ≤ 7 days of IV therapy from surgery will be included. A total of 308 participants will be centrally computer-randomized to PO or IV antibiotics to complete the first 6 weeks of therapy. Follow-on PO therapy will be permitted in either arm. The primary outcome is the proportion of participants experiencing treatment failure within 1 year. An associated cost-effectiveness evaluation including complications, resource utilization and quality-of-life data will be performed.
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
- 是
入选标准
- •aged ≥ 18 years
- •willing and able to give informed consent
- •primary THA or TKA diagnosed with PJI based on International Consensus Meeting criteria
- •A sinus communicating with the prosthesis OR
- •Two positive cultures obtained from the prosthesis OR
- •3 of 5 criteria:
- •Elevated ESR (>30mm/hr) and CRP (>10mg/L)
- •Elevated synovial leukocyte count (>3000 cells/µL) or change of ++ on leukocyte esterase strip
- •Elevated synovial neutrophil percentage (>80%)
- •One positive culture
- •Positive histological analysis of periprosthetic tissue (>5 neutrophils per high power field in 5 high power fields x400)
- •PJI treated by debridement and implant retention, or excision of the prosthetic joint (with or without planned reimplantation)
- •received ≤ 7 days of IV therapy after an appropriate surgical intervention
排除标准
- •Previously treated for native septic arthritis or PJI in the same joint
- •S. aureus bacteremia on presentation or within the previous month
- •clinical, histological or microbiological evidence of mycobacterial, fungal or parasitic etiology of the infection
- •any other concomitant infection that, in the opinion of the clinician responsible for the patient, requires a prolonged course of IV antibiotic therapy (e.g. bacterial endocarditis, mediastinal infection, central nervous system infection)
- •septic shock or systemic features that, in the opinion of the clinician responsible for the patient, requires a course of IV antibiotic therapy (the patient could be re-evaluated if these features resolved)
- •an infection for which there are no suitable antibiotic choices to permit randomization between the two arms of the trial (e.g. when organisms are only sensitive to IV antibiotics or PO antibiotics)
- •unlikely to comply with trial requirements following randomization in the opinion of the investigator
研究组 & 干预措施
Oral Antibiotics
Participant will receive 6 weeks of oral antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor.
干预措施: Bactrim (Drug)
Oral Antibiotics
Participant will receive 6 weeks of oral antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor.
干预措施: Cefadroxil (Drug)
Oral Antibiotics
Participant will receive 6 weeks of oral antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor.
干预措施: Doxycycline Hcl (Drug)
Oral Antibiotics
Participant will receive 6 weeks of oral antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor.
干预措施: Clindamycin (Drug)
Intravenous Antibiotics
Participant will receive 6 weeks of intravenous (IV) antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor.
干预措施: Bactrim (Drug)
Intravenous Antibiotics
Participant will receive 6 weeks of intravenous (IV) antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor.
干预措施: Cefadroxil (Drug)
Intravenous Antibiotics
Participant will receive 6 weeks of intravenous (IV) antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor.
干预措施: Doxycycline Hcl (Drug)
Intravenous Antibiotics
Participant will receive 6 weeks of intravenous (IV) antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor.
干预措施: Clindamycin (Drug)
结局指标
主要结局
Rate of Postoperative Infections
时间窗: 2 years
The investigator will measure the incidence of postoperative infections in participants treated with oral antibiotics versus those treated with intravenous antibiotics
次要结局
未报告次要终点