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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04409769
Enrollment
22
Registered
2020-06-01
Start date
2020-02-01
Completion date
2020-05-05
Last updated
2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Reaction, Bone and Joint Infection

Keywords

bone and joint infection, prosthesis joint infection, adverse event, ceftaroline, ceftobiprole

Brief summary

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.

Interventions

OTHERDescription 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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
rate of failure under ceftobiproleOutcome 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 ceftaroline and ceftobiprole : patientsOutcome 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: dosageOutcome 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/BJIOutcome 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: dosageOutcome 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/BJIOutcome 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 ceftarolineOutcome 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

MeasureTime frameDescription
Treatment-related adverse events2 monthsdescription of adverse event under ceftaroline and/or ceftobiprole as assessed by CTCAE v4.0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026