Impact of Rifampicin in Treatment Outcome of Cutibacterium Acnes Prosthetic Joint Infections
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 235
- 试验地点
- 25
- 主要终点
- Rate of C. acnes prosthetic joint infections management failure
研究概览
简要总结
Cutibacterium acnes is involved in nearly 40% of shoulder prosthetic joint infections (PJI). After shoulder prothesis, C. acnes mainly affects hip prosthesis. One recent work from the Lyon (France) bone and joint infections reference center with data focusing mainly on hip and knee PJI has reported that C. acnes is the leading cause of late-onset PJI after coagulase negative staphylococci (CNS) (late acute PJI not considered).
In such late-onset device-related infection, biofilm, as produced by C. acnes during PJI represents a major hurdle on the path to patient's cure. Because biofilm-associated bacteria have a slower metabolism and a lower multiplication rate than planktonic bacteria, antibiotic susceptibility can be hampered.
Rifampicin is an antibiotic with low minimal bactericidal concentration against S. aureus and CNS biofilm-associated bacteria8 which significantly influence patient's outcome during staphylococci PJI.
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
- •Age: > or =18 years old;
- •Monomicrobial, rifampicin susceptible Cutibacterium acnes late total knee arthroplasty (TKA) or hip arthroplasty (total, THA or hemiarthroplasty, HH) or shoulder arthroplasty (total, TSA or hemiarthroplasty, SH) infection treated surgically with single-stage or two-stage revision;
- •Isolation of C. acnes on two distinct per-operative samples collected during the single-stage or the two-stage revision
- •Based on the antimicrobial susceptibility test of the C. acnes and the medical history of the patient, the PJI can be treated with amoxicillin or moxifloxacin;
- •Women considered of childbearing potential (WOCBP) requires use of a highly effective contraceptive measure as intrauterine device (IUD), intrauterine hormone-releasing system (IUS), documented bilateral tubal occlusion, documented vasectomised partner, sexual abstinence. Contraception should be maintained during treatment and until the end of relevant systemic exposure.
排除标准
- •Contraindication to Rifampicin (included ongoing treatment contraindicated with rifampicin)
- •Contraindication to Amoxicillin AND moxifloxacin (included ongoing treatment contraindicated with these medicines)
- •Empirical antibiotic treatment not administered during the 24 hours following revision surgery;
- •Inactive empirical antibiotic treatment following surgery according to the AST of the bacteria;
- •disease-modifying treatment incompatible with the inducer effect of rifampicin
- •Liver cirrhosis;
- •Pregnancy: a pregnancy blood test will be performed on all women of childbearing age. The results will be sent to the patient by the doctor of their choice;
- •Porphyria;
- •Renal insufficiency with GFR < 30ml/min/1.73 m2 (CKD-EPI);
研究组 & 干预措施
Antibiotic treatment backbone + rifampicin
Amoxicillin or moxifloxacin to the investigator's discretion + RIMACTAN
干预措施: amoxicillin or moxifloxacin + rifampicin (Drug)
Antibiotic treatment backbone alone
Amoxicillin or moxifloxacin to the investigator's discretion
干预措施: amoxicillin or moxifloxacin (Drug)
结局指标
主要结局
Rate of C. acnes prosthetic joint infections management failure
时间窗: 24 months after the end of antibiotic treatment
Defined by Relapse, New infection, early failure
Rate of adverse event linked to rifampicin
时间窗: during rifampicin treatment
adverse events will be described by frequency and grade, throughout the treatment (classified according to the CTCAE 5.0.)
次要结局
- Rate of C. acnes prosthetic joint infections probable failure(24 months after the end of antibiotic treatment)
- Rate of C. acnes prosthetic joint infections management failure(12 months after the end of antibiotic treatment)
- Rate of C. acnes prosthetic joint infections management failure(24 months after the end of antibiotic treatment)