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

Bone and Joint Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409769
• Other study ID #: 20-157
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: May 5, 2020

Study information

• Verified date: June 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 5, 2020
• Est. primary completion date: May 5, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Antibiotic Reaction
• Bone and Joint Infection
• Infection

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Treatment-related adverse events	description of adverse event under ceftaroline and/or ceftobiprole as assessed by CTCAE v4.0	2 months

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