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

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.

Study Overview

• Status: Completed
• Conditions: Antibiotic Reaction; Bone and Joint Infection
• Intervention / Treatment: Other: Description of use of ceftaroline and ceftobiprole

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients having had a PJI or BJI treated whith ceftaroline and/or ceftobiprole treated at CRIOAc Lyon

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Description of use of ceftaroline and ceftobiprole; description of patients and their PJI/BJI,conditions of use, adverse event	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of use of ceftaroline and ceftobiprole : patients	type of patients: age, CMI	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Evaluation of use of ceftaroline: dosage	dosage,duration	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Evaluation of use of ceftaroline : PJI/BJI	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	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Evaluation of use of ceftobiprole: dosage	dosage, duration	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Evaluation of use of ceftobiprole: PJI/BJI	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	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
rate of failure under ceftaroline	Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
rate of failure under ceftobiprole	Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): May 5, 2020
• Study Completion (Actual): May 5, 2020

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: bone and joint infection; ceftaroline; prosthesis joint infection; ceftobiprole; adverse event
• Additional Relevant MeSH Terms: Infections; Anti-Infective Agents; Anti-Bacterial Agents; Ceftaroline fosamil; Ceftobiprole; Ceftobiprole medocaril
• Other Study ID Numbers: 20-157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No