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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04409769
Other study ID # 20-157
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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:

-

Study Design


Related Conditions & MeSH terms


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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