Bone and Joint InfectionNCT04409769
Evaluation of the Tolerance of Ceftaroline and Ceftobiprole in the Management of BJI / PJI
An observational study of Bone and Joint Infection and Antibiotic Reaction, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone and Joint Infection, Antibiotic Reaction
- What is being tested?
- Description of use of ceftaroline and ceftobiprole
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2020to 5 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients having had a PJI or BJI treated whith ceftaroline and/or ceftobiprole treated at CRIOAc Lyon
Who may be able to join
- patients having had a PJI or BJI treated whith ceftaroline and/or ceftobiprole
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Bone and Joint Infection, Antibiotic Reaction
- Being tested
- Description of use of ceftaroline and ceftobiprole
- Keywords
- bone and joint infection, prosthesis joint infection, adverse event, ceftaroline, ceftobiprole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Description of use of ceftaroline and ceftobiprole | description of patients and their PJI/BJI,conditions of use, adverse event Receives: Other: Description of use of ceftaroline and ceftobiprole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of use of ceftaroline and ceftobiprole : patients
type of patients: age, CMI
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
description of adverse event under ceftaroline and/or ceftobiprole as assessed by CTCAE v4.0
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Feb 2020
- Primary completion5 May 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Joint InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409769
- Sponsor's protocol ID
- 20-157
- Status last verified
- Jun 2020
- First submitted
- 12 May 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04409769
- Acronym / sponsor ID
- 20-157
- Conditions
- Bone and Joint Infection, Antibiotic Reaction
- Keywords
- bone and joint infection, prosthesis joint infection, adverse event, ceftaroline, ceftobiprole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Description of use of ceftaroline and ceftobiprole | – | Other: Description of use of ceftaroline and ceftobiproledescription of patients and their PJI/BJI,conditions of use, adverse event |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients having had a PJI or BJI treated whith ceftaroline and/or ceftobiprole treated at CRIOAc Lyon
Key inclusion criteria (1 listed)
- patients having had a PJI or BJI treated whith ceftaroline and/or ceftobiprole
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Description of use of ceftaroline and ceftobiproleCeftaroline and ceftobiprole are the only betalactam active on methicillin-resistant staphylococci. Description of condition of use of thoses antibiotics in PJI and BJI | Other | Description of use of ceftaroline and ceftobiprole |
Primary outcome
Evaluation of use of ceftaroline and ceftobiprole : patients
Time frame: 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: dosage
Time frame: 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 : PJI/BJI
Time frame: 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
Time frame: 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 ceftobiprole: PJI/BJI
Time frame: 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
Time frame: 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
rate of failure under ceftobiprole
Time frame: 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
1 secondary outcome
Treatment-related adverse events
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone and Joint Infection and Antibiotic Reaction, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of use of ceftaroline and ceftobiprole : patients (time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.