2024-519894-20-01招募中3 期
RIFAMAB : Rifabutin versus rifampicin for treatment of staphylococcal prosthetic joint infection treated with debridement, antibiotics and implant retention (DAIR strategy): a multicenter randomized, open-label, non-inferiority trial
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 436
- 试验地点
- 33
- 主要终点
- The primary outcome is treatment failure after one year of follow-up, defined as one of following events: The need for any further surgical procedure – i.e. implants removal, implants exchange or amputation; And/or PJI related death; And/or use of suppressive antibiotic therapy that was not planned before randomization
研究概览
简要总结
To demonstrate that in DAIR strategy for prosthetic joint infection due to staphylococci (S. aureus and CoNS) susceptible or resistant to methicillin, oral rifabutin is non-inferior to oral rifampicin.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Hip or knee Prosthetic joint infection treated by debridement, antibiotic therapy initiation and retention of prothesis (DAIR strategy)
- •Microbiologically documented infection corresponds to the isolation of staphylococcus aureus or coagulase-negative Staphylococcus aureus from reliable samples: intraoperatively (≥ 3 during synovectomywashing), joint puncture or blood culture; the microorganism(s) will be considered pathogenic if identified in ≥ 2 reliable samples.
- •Microorganisms susceptible to rifampicin and at least one other antibiotic suitable for the treatment of PJI (e.g., penicillin, fluoroquinolone, (doxy/mino)cycline, oxazolidinone, cotrimoxazole, daptomycin, glycopeptide, macrolide, fusidic acid), regardless of sensitivity to methicillin.
- •Age ≥ 18 years
- •At least 2 days of appropriate (i.e., covering pathogen(s) identified in the intraoperative samples) empirical agents are needed.
- •Signed Inform consent
- •Patient having the rights to French social insurance
- •For women of childbearing potential i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile and excluding oestroprogestative-based contraception, any effective contraceptive: vasectomy (for men), intrauterine device copper, feminine sterilization, condom, sexual abstinence is required. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
排除标准
- •Known or suspected malabsorption (imperfect absorption of food material by the small intestine)
- •Ongoing treatment that contraindicates the use of rifampicin or rifabutine
- •Unable to take oral treatment
- •Receive empirical postoperative antibiotic treatment by rifampicin or rifabutin prior to randomization
- •Pregnancy or lactating women
- •Curator or guardianship or patient placed under judicial protection
- •Participation in other interventional research during the study
- •Polymicrobial infection due to other than staphylococcus species susceptible to rifampicin
- •Known or suspected allergy to rifabutin and/or rifampicin
- •Diagnosis of endocarditis associated to PJI
- •Renal transplant or Chronic kidney disease with an eGFR of less than 30ml/min/1.73m²
- •Other Solid Organ Transplant
- •Liver cirrhosis, Child-Pugh score C
- •Any other concomitant infection which required a prolonged course of intravenous antibiotic therapy
- •Oestroprogestative-based contraception
结局指标
主要结局
The primary outcome is treatment failure after one year of follow-up, defined as one of following events: The need for any further surgical procedure – i.e. implants removal, implants exchange or amputation; And/or PJI related death; And/or use of suppressive antibiotic therapy that was not planned before randomization
The primary outcome is treatment failure after one year of follow-up, defined as one of following events: The need for any further surgical procedure – i.e. implants removal, implants exchange or amputation; And/or PJI related death; And/or use of suppressive antibiotic therapy that was not planned before randomization
次要结局
- Proportion of patient which are free from SAEs occurrence, as defined by: o Patients who completed the entire 12 weeks’ duration of antibiotic treatment planned initially and; Who did not experience grade 3-4 adverse events, including death, regardless of the link with antibiotic therapy; Who did not experience adverse events which led to either to: • Reduce the dosage or split the treatment to two take/day; • Or stop any component of the antibiotic treatment.
- Number and rate of patients in each arm who experiences: o Liver cytolysis (>=2N for ALT AND/OR AST) o Acute Kidney failure as defined by serum creatinine increase in KDIGO o Digestive symptoms, including diarrhea o Who required a modification of antibiotic dosage during the 12 weeks’ period of antibiotic treatment o Uveitis/ophthalmologic disorder o Neurological disorder
- Early termination rate will be measured in each arm, as the number of patients having stopped rifampicin or rifabutin before the planned 12 weeks’ period over the total number of patients enrolled in the studied arm.
- Adherence rate to medication will be measured as the number of days on which all doses were missed over the number of days of planned antibiotic therapy. Patients enrolled in the study will have to fill their pill count in a daily notebook.
- Quality of life, as evaluated by the use EQ5D5L auto-questionnaire at week 6, month 6, month 12 and month 24 as used in previous randomized clinical trial on bone and joint infection.
- Oxford Hip and Knee Scores evolution between week 6, month 6, month 12 and month 24 as used in previous randomized clinical trial on bone and joint infection.
- Long term efficacy: treatment failure, as defined for primary outcome, occurring between 12 months and 24 months after initial surgery.
研究者
Jean-Jacques VITAGLIANO
Scientific
Centre Hospitalier De Tourcoing
研究点 (33)
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