Bone and Joint InfectionNCT03850860
Comparison of Two Empirical Antimicrobial Therapies of Prosthetic Joint Infection
An observational study of Bone and Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. T Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bone and Joint Infection
- What is being tested?
- empirical antibiotherapy
- How many people
- 178 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2018to 1 Jun 2019
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: patients having had a prosthetic joint infection and having had a postoperative empirical antibiotherapy with combination of vancomycine and piperacillin-tazobactam or vancomycine and cefepime manage at the croix rousse hospital
Who may be able to join
- patients having had a prosthetic joint infection and having had a postoperative empirical antibiotherapy with combination of vancomycine and piperacillin-tazobactam or vancomycine and cefepime
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Tolerance of Vancomycin in Combination With Piperacillin/Tazobactam or Cefepim as Empirical Antimicrobial Therapy of Prosthetic Joint Infection
The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. T
Read the detailed description
The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. The empirical antimicrobial therapy of PJI is associated with an important rate of adverse, linked with the use of the vancomycin and the piperacillin-tazobactam combination. Some studies suggest to use vancomycin-cefepime, which remains to be evaluated in PJI.
- Conditions
- Bone and Joint Infection
- Being tested
- empirical antibiotherapy
- Keywords
- prosthetic joint infection, empirical antibiotherapy, acute kidney injury, vancomycin, cefepim, Piperacillin/tazobactam
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empirical antibiotherapyOther
comparison of the outcome in the 2 groups having had 2 different empirical antibiotherapies
| Study group | Role | What they receive |
|---|---|---|
| empirical antibotherapy currently used | patients having had a vancomycin and piperacillin-tazobactam combination as empirical antibiotherapy Receives: Other: empirical antibiotherapy | |
| another empirical antibotherapy | patients having had a vancomycin and cefepime combination as empirical antibiotherapy Receives: Other: empirical antibiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Treatment Failure
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 (2)
rate of adverse events
Description of adverses events leading to stop the empirical treatment
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
rate of bacteria responsible for infection
bacterial epidemiology
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Dec 2018
- Primary completion1 Mar 2019
- Study completion1 Jun 2019
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugénie MABRUT, Hospices Civils de Lyon
- Investigators
- Florent Valour, Md,PhD, Study director, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850860
- Sponsor's protocol ID
- 18-326
- Status last verified
- Sep 2023
- First submitted
- 20 Feb 2019
- Last updated
- 22 Sep 2023
- 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Tolerance of Vancomycin in Combination With Piperacillin/Tazobactam or Cefepim as Empirical Antimicrobial Therapy of Prosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT03850860
- Acronym / sponsor ID
- 18-326
- Conditions
- Bone and Joint Infection
- Keywords
- prosthetic joint infection, empirical antibiotherapy, acute kidney injury, vancomycin, cefepim, Piperacillin/tazobactam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 22 Feb 2019 (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.
The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. T
Detailed description
The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. The empirical antimicrobial therapy of PJI is associated with an important rate of adverse, linked with the use of the vancomycin and the piperacillin-tazobactam combination. Some studies suggest to use vancomycin-cefepime, which remains to be evaluated in PJI.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| empirical antibotherapy currently used | – | Other: empirical antibiotherapypatients having had a vancomycin and piperacillin-tazobactam combination as empirical antibiotherapy |
| another empirical antibotherapy | – | Other: empirical antibiotherapypatients having had a vancomycin and cefepime combination as empirical antibiotherapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients having had a prosthetic joint infection and having had a postoperative empirical antibiotherapy with combination of vancomycine and piperacillin-tazobactam or vancomycine and cefepime manage at the croix rousse hospital
Key inclusion criteria (1 listed)
- patients having had a prosthetic joint infection and having had a postoperative empirical antibiotherapy with combination of vancomycine and piperacillin-tazobactam or vancomycine and cefepime
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| empirical antibiotherapycomparison of the outcome in the 2 groups having had 2 different empirical antibiotherapies | Other | another empirical antibotherapy, empirical antibotherapy currently used |
Primary outcome
Rate of Treatment Failure
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
2 secondary outcomes
rate of adverse events
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
rate of bacteria responsible for infection
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
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 22 Sep 2023.
- 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.
Florent Valour, Md,PhD study director
HCL
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, 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 22 Sep 2023. 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?
Rate of Treatment Failure (time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption). 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 22 Sep 2023.