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临床试验/NCT04409769
NCT04409769已完成不适用

Evaluation of the Tolerance of Anti-MRSA Betalactamines (Ceftaroline / Ceftobiprole) in the Management of BJI / PJI: a Retrospective Study in a Reference Center

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Evaluation of use of ceftaroline and ceftobiprole : patients

研究概览

简要总结

Staphyloccous aureus and coagulase negative staphylocci are responsible of a large marjority of PJI. Regarding the high rate of methicillin resistance, current guidelines recommend the use of a glycopeptide, and most frequently vancomycin, as the anti-gram positive agent in empirical therapy, while awaiting the microbiological results. Vancomycin is not considered as a safe antibiotic, and daptomycin is frequently an alternative option.

Ceftaroline and ceftobiprole are the only betalactam active on methicillin-resistant staphylococci. As some data report a synergistic activity with daptomycin, they could be an option in pandrug-resistant staphylococci BJI, but their use if off label in this indication.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients having had a PJI or BJI treated whith ceftaroline and/or ceftobiprole

排除标准

  • 未提供

结局指标

主要结局

Evaluation of use of ceftaroline and ceftobiprole : patients

时间窗: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

type of patients: age, CMI

Evaluation of use of ceftaroline : PJI/BJI

时间窗: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

description of the PJI/BJI treated by ceftaroline : presence of knee or hip prosthesis, evolution between prosthesis placement and the onset of symptoms, gateway to infection

Evaluation of use of ceftobiprole: dosage

时间窗: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

dosage, duration

Evaluation of use of ceftaroline: dosage

时间窗: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

dosage,duration

rate of failure under ceftobiprole

时间窗: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin

Evaluation of use of ceftobiprole: PJI/BJI

时间窗: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

description of the PJI/BJI treated by ceftobiprole : presence of knee or hip prosthesis, evolution between prosthesis placement and the onset of symptoms, gateway to infection

rate of failure under ceftaroline

时间窗: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin

次要结局

  • Treatment-related adverse events(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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