NCT04409769

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

May 12, 2020

Last Update Submit

June 3, 2020

Conditions

Bone and Joint InfectionAntibiotic Reaction

Keywords

bone and joint infectionprosthesis joint infectionadverse eventceftarolineceftobiprole

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (1)

  • Treatment-related adverse events

    2 months

Study Arms (1)

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

Interventions

Description of use of ceftaroline and ceftobiproleOTHER

Ceftaroline and ceftobiprole are the only betalactam active on methicillin-resistant staphylococci. Description of condition of use of thoses antibiotics in PJI and BJI

Description of use of ceftaroline and ceftobiprole

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

Location

Related Links

MeSH Terms

Interventions

ceftobiprole

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2020

First Posted

June 1, 2020

Study Start

February 1, 2020

Primary Completion

May 5, 2020

Study Completion

May 5, 2020

Last Updated

June 5, 2020

Record last verified: 2020-06

Locations

FR(1)