Prosthetic Joint InfectionBJIBiofilmNCT03263832
Evaluation of the Antibiofilmogramme Test During Orthopaedic Device-Related Infection
An observational study of Prosthetic Joint Infection and Staphylococcus Aureus, run by BioFilm Control at 1 site in France.
Trial summary
This is an observational study that does not change routine care. The primary objective of this study is to investigate the correlation between the administration of an antibiotherapy able to prevent biofilm formation according to the results of the Antibiofilmogramme test, and the relapse of the infection for patient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infection, Staphylococcus Aureus, Biofilm
- What is being tested?
- Antibiofilmogramme
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2015to 1 Dec 2021
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population is composed of patient with a monomicrobial S. aureus orthopaedic device-related infections.
Who may be able to join
- The patient must have been informed and received a non-opposition consent form
- Patient with a monomicrobial S. aureus bone and joint infections
- Patient with prosthetic or orthopaedic device
Who cannot join
- Bone and joint infection from pressure ulcer, vascular injury or diabetic foot ulcer
- Polymicrobial prosthetic joint infection
- The patient is participating in, or has participated in within the past 3 months, another interventional study, or is currently in an exclusion period determined by a preceding study
- Patient is under judicial protection, under tutorship or curatorship
- The patient expresses his opposition to participate to the study
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient or breastfeeding
- Emergency situation precluding correct study implementation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Demonstration of Clinical Value of Antibiofilmogramme Test for Monomicrobial S. Aureus Orthopaedic Device-Related Infection
This is an observational study that does not change routine care.
The primary objective of this study is to investigate the correlation between the administration of an antibiotherapy able to prevent biofilm formation according to the results of the Antibiofilmogramme test, and the relapse of the infection for patient with orthopaedic device-related infection.
Read the detailed description
The secondary objectives are:
- Investigate the role of antibiogram-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in orthopaedic device-related infection management.
- Investigate the capacity of S. aureus isolates to form biofilm in presence/absence of antibiotics.
- Create an S. aureus strain collection for future ancillary studies
- Conditions
- Prosthetic Joint Infection, Staphylococcus Aureus, Biofilm
- Being tested
- Antibiofilmogramme
- Keywords
- Antibiogramme, Antibiofilmogramme
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibiofilmogrammeDiagnostic test
An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Patients with a monomicrobial S. aureus orhtopaedic device-related infection who have received antibiotherapy able to prevent biofilm formation following surgical intervention (from day 0 to day 7).
Upon inclusion, antibiograms were performed on the S. aureus isolated as part of routine procedure. S. aureus isolates was further analysed via an Antibiofilmogramme, which is an experimental element added by this research. Receives: Diagnostic Test: Antibiofilmogramme | |
| Not Exposed | Patients with a monomicrobial S. aureus orhtopaedic device-related infection who not have received antibiotherapy able to prevent biofilm formation following surgical intervention (from day 0 to day 7).
Upon inclusion, antibiograms were performed on the S. aureus isolated as part of routine procedure. S. aureus isolates was further analysed via an Antibiofilmogramme, which is an experimental element added by this research. Receives: Diagnostic Test: Antibiofilmogramme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or treatment failure
Presence or absence of microbiological treatment failure confirmed by S. aureus positive clinical samples. The diagnostic of a S. aureus positive clinical sample indicated a treatment failure. Treatment success corresponded to an absence of clinical or microbiological treatment failure, or treatment failure with positive clinical sample other than S. aureus.
Measured: From surgical intervention to one year after the end of antimicrobial therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start1 Jun 2015
- Primary completion28 Feb 2018
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Joint InfectionStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 45 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- BioFilm Control
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Sponsor
- Investigators
- Frederic Laurent, PharmD - PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263832
- Sponsor's protocol ID
- 2015-A0022472
- Acronym
- BJIBiofilm
- Status last verified
- Mar 2021
- First submitted
- 23 Aug 2017
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of Clinical Value of Antibiofilmogramme Test for Monomicrobial S. Aureus Orthopaedic Device-Related Infection
- ClinicalTrials.gov ID
- NCT03263832
- Acronym / sponsor ID
- BJIBiofilm / 2015-A0022472
- Conditions
- Prosthetic Joint Infection, Staphylococcus Aureus, Biofilm
- Keywords
- Antibiogramme, Antibiofilmogramme
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- BioFilm ControlIndustry (pharma, biotech, devices)
- Collaborators
- Hospices Civils de Lyon
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 28 Aug 2017 (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.
This is an observational study that does not change routine care.
The primary objective of this study is to investigate the correlation between the administration of an antibiotherapy able to prevent biofilm formation according to the results of the Antibiofilmogramme test, and the relapse of the infection for patient with orthopaedic device-related infection.
Detailed description
The secondary objectives are:
- Investigate the role of antibiogram-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in orthopaedic device-related infection management.
- Investigate the capacity of S. aureus isolates to form biofilm in presence/absence of antibiotics.
- Create an S. aureus strain collection for future ancillary studies
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Diagnostic Test: AntibiofilmogrammePatients with a monomicrobial S. aureus orhtopaedic device-related infection who have received antibiotherapy able to prevent biofilm formation following surgical intervention (from day 0 to day 7). Upon inclusion, antibiograms were performed on the S. aureus isolated as part of routine procedure. S. aureus isolates was further analysed via an Antibiofilmogramme, which is an experimental element added by this research. |
| Not Exposed | – | Diagnostic Test: AntibiofilmogrammePatients with a monomicrobial S. aureus orhtopaedic device-related infection who not have received antibiotherapy able to prevent biofilm formation following surgical intervention (from day 0 to day 7). Upon inclusion, antibiograms were performed on the S. aureus isolated as part of routine procedure. S. aureus isolates was further analysed via an Antibiofilmogramme, which is an experimental element added by this research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of patient with a monomicrobial S. aureus orthopaedic device-related infections.
Key inclusion criteria (3 listed)
- The patient must have been informed and received a non-opposition consent form
- Patient with a monomicrobial S. aureus bone and joint infections
- Patient with prosthetic or orthopaedic device
Key exclusion criteria (8 listed)
- Bone and joint infection from pressure ulcer, vascular injury or diabetic foot ulcer
- Polymicrobial prosthetic joint infection
- The patient is participating in, or has participated in within the past 3 months, another interventional study, or is currently in an exclusion period determined by a preceding study
- Patient is under judicial protection, under tutorship or curatorship
- The patient expresses his opposition to participate to the study
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 |
|---|---|---|
| AntibiofilmogrammeAn Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate. | Diagnostic test | Exposed, Not Exposed |
Primary outcome
Success or treatment failure
Time frame: From surgical intervention to one year after the end of antimicrobial therapy.
Presence or absence of microbiological treatment failure confirmed by S. aureus positive clinical samples. The diagnostic of a S. aureus positive clinical sample indicated a treatment failure. Treatment success corresponded to an absence of clinical or microbiological treatment failure, or treatment failure with positive clinical sample other than S. aureus.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
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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.
Frederic Laurent, PharmD - PhD principal investigator
Hospices Civils de Lyon
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 Prosthetic Joint Infection and Staphylococcus Aureus, run by BioFilm Control 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 2 Mar 2021. 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?
Results are not available in the source record.
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?
Success or treatment failure (time frame: From surgical intervention to one year after the end of antimicrobial therapy.). 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 2 Mar 2021.