Clinical trial NCT04409769: Evaluation of the Tolerance of Ceftaroline and Ceftobiprole in the Management of BJI / PJI
Official title: 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: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone and Joint Infection
Antibiotic Reaction
Keywords: bone and joint infection
prosthesis joint infection
adverse event
ceftaroline
ceftobiprole
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having had a PJI or BJI treated whith ceftaroline and/or ceftobiprole treated at CRIOAc Lyon

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Evaluation of use of ceftaroline and ceftobiprole : patients
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
measure: Evaluation of use of ceftaroline: dosage
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
measure: Evaluation of use of ceftaroline : PJI/BJI
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
measure: Evaluation of use of ceftobiprole: dosage
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
measure: Evaluation of use of ceftobiprole: PJI/BJI
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
measure: rate of failure under ceftaroline
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
measure: rate of failure under ceftobiprole
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Secondary outcomes:
measure: Treatment-related adverse events
timeFrame: 2 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References: