Evaluation of the Tolerance of Ceftaroline and Ceftobiprole in the Management of BJI / PJI

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: May 5, 2020

Interventions

  • Other: Description of use of ceftaroline and ceftobiprole
    • Ceftaroline and ceftobiprole are the only betalactam active on methicillin-resistant staphylococci. Description of condition of use of thoses antibiotics in PJI and BJI

Arms, Groups and Cohorts

  • Description of use of ceftaroline and ceftobiprole
    • description of patients and their PJI/BJI,conditions of use, adverse event

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of use of ceftaroline and ceftobiprole : patients
    • Time Frame: 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: dosage
    • Time Frame: 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 : PJI/BJI
    • Time Frame: 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
    • Time Frame: 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 ceftobiprole: PJI/BJI
    • Time Frame: 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
    • Time Frame: 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
  • rate of failure under ceftobiprole
    • Time Frame: 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

Secondary Measures

  • Treatment-related adverse events
    • Time Frame: 2 months
    • description of adverse event under ceftaroline and/or ceftobiprole as assessed by CTCAE v4.0

Participating in This Clinical Trial

Inclusion Criteria

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

-

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor

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