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

Completed

• Conditions: Antibiotic Reaction; Bone and Joint Infection
• Interventions: Other: Description of use of ceftaroline and ceftobiprole

• Registration Number: NCT04409769
• Lead Sponsor: Hospices Civils de 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2020-05-05
• Study Completion: 2020-05-05
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-26
• Status Verified: 2020-06
• Study First Posted: 2020-06-01
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Evaluation of use of ceftaroline and ceftobiprole : patients	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	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	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	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	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	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France