Bone and Joint Prosthetic InfectionsNCT02222792
BJI Inoplex 2 : Test for Diagnosis of Prosthetic Infections
An observational study of Bone and Joint Prosthetic Infections, run by Diaxonhit at 2 sites in France.
Trial summary
A national, prospective, open-label, non-interventional, multicentre, controlled study designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder prosthetic removal regardless of whether or not infection is suspected. Serological test results will have no impact on the therapeutic approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone and Joint Prosthetic Infections
- How many people
- 540 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2012to Jul 2016
- 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 septic patient group will be comprised of patients presenting with bone and joint prosthetic device infection confirmed by intraoperative microbiological culture (at least 2 deep positive samples for the same bacterial strain). The non-septic patient group will be comprised of prosthetic patients presenting with symptoms of mechanical loosening, and whose deep intraoperative samples have all proved negative.
Who may be able to join
- Male or female patients
- Patients 18 years of age or older
- Patient with a bone and joint prosthetic device: total hip prosthesis (THP) or total knee prosthesis (TKP) or total shoulder prosthesis (TSP)
- Patients with a revision of a failed prosthesis, regardless of the cause and whether septic or not
- Patients who have not expressed their opposition to the use of their personal medical data and blood samples
Who cannot join
- Patients already enrolled or clinically reviewed following a relapse
- Patients with several prostheses requiring at least two revisions during the same surgical procedure
- Patients for whom the microbiologist and/or doctor responsible for the care refuses that these patients participate in the study
- HIV+ patients
- Patients undergoing chemotherapy for a blood disease or solid tumour
- Patients under guardianship or trusteeship
- Patients who are expected to be difficult to monitor (life expectancy less than 1 year, or homeless people, foreigner in transit)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
Groupe hospitalier Diaconesses Croix Saint Simon
Paris, 75012
About this study
Official title: Evaluation of the BJI Inoplex 2 Kit for the Multiplex Serological Diagnosis of Bone and Joint Prosthetic Device Infections
A national, prospective, open-label, non-interventional, multicentre, controlled study designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder prosthetic removal regardless of whether or not infection is suspected. Serological test results will have no impact on the therapeutic approach.
Study objective: To evaluate the diagnostic performance of an antibody detection kit for the serological diagnosis of bone and joint prosthetic device infections cause by Staphylococci, Streptococci, Propionibacterium acnes (P. acnes) and Gram-negative bacteria versus the reference method: the bacterial culture of deep intraoperative samples.
- Conditions
- Bone and Joint Prosthetic Infections
- Keywords
- Staphylococci, Streptococci, P acnes and Gram-negative bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Septic patient group | The septic patient group will be comprised of patients presenting with bone and joint prosthetic device infection confirmed by intraoperative microbiological culture (at least 2 deep positive samples for the same bacterial strain). | |
| Non-septic patient group | The non-septic patient group will be comprised of prosthetic patients presenting with symptoms of mechanical loosening, and whose deep intraoperative samples have all proved negative | |
| Intermediate group | An intermediate group will be comprised of patients with only one deep positive sample. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of test BJI 2
The diagnostic performance of the test during unique titration.
- Sensitivity: estimated from the proportion of septic group patients with an antibody level above the defined threshold antibody concentration.
- Specificity: estimated from the proportion of non-septic-group patients with an antibody level less than or equal to the defined threshold antibody concentration.
- Positive likelihood ratio.
- Negative likelihood ratio.
Measured: 2 years
Secondary outcomes (1)
Interest of test BJI 2
- To evaluate the diagnostic interest of the BJI Inoplex 2 test in conjunction with the clinical and laboratory data collected: diagnostic strategy and score combining several criteria.
- To evaluate the potential medical and economic benefits of using the test: number and cost of joint aspirations or hospital stays that would have been avoided, delayed diagnosis.
- To describe the serological outcome after surgery in septic patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startJun 2012
- Primary completionMay 2014
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Joint Prosthetic InfectionsStudies 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
- Time perspective
- Prospective
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diaxonhit
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222792
- Sponsor's protocol ID
- BJI 2
- Status last verified
- Aug 2014
- First submitted
- 19 Aug 2014
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the BJI Inoplex 2 Kit for the Multiplex Serological Diagnosis of Bone and Joint Prosthetic Device Infections
- ClinicalTrials.gov ID
- NCT02222792
- Acronym / sponsor ID
- BJI 2
- Conditions
- Bone and Joint Prosthetic Infections
- Keywords
- Staphylococci, Streptococci, P acnes and Gram-negative bacteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- DiaxonhitIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2016 (estimated)
- First posted
- 21 Aug 2014 (estimated)
- 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.
A national, prospective, open-label, non-interventional, multicentre, controlled study designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder prosthetic removal regardless of whether or not infection is suspected. Serological test results will have no impact on the therapeutic approach.
Study objective: To evaluate the diagnostic performance of an antibody detection kit for the serological diagnosis of bone and joint prosthetic device infections cause by Staphylococci, Streptococci, Propionibacterium acnes (P. acnes) and Gram-negative bacteria versus the reference method: the bacterial culture of deep intraoperative samples.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Septic patient group | – | –The septic patient group will be comprised of patients presenting with bone and joint prosthetic device infection confirmed by intraoperative microbiological culture (at least 2 deep positive samples for the same bacterial strain). |
| Non-septic patient group | – | –The non-septic patient group will be comprised of prosthetic patients presenting with symptoms of mechanical loosening, and whose deep intraoperative samples have all proved negative |
| Intermediate group | – | –An intermediate group will be comprised of patients with only one deep positive sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The septic patient group will be comprised of patients presenting with bone and joint prosthetic device infection confirmed by intraoperative microbiological culture (at least 2 deep positive samples for the same bacterial strain). The non-septic patient group will be comprised of prosthetic patients presenting with symptoms of mechanical loosening, and whose deep intraoperative samples have all proved negative.
Key inclusion criteria (5 listed)
- Male or female patients
- Patients 18 years of age or older
- Patient with a bone and joint prosthetic device: total hip prosthesis (THP) or total knee prosthesis (TKP) or total shoulder prosthesis (TSP)
- Patients with a revision of a failed prosthesis, regardless of the cause and whether septic or not
- Patients who have not expressed their opposition to the use of their personal medical data and blood samples
Key exclusion criteria (7 listed)
- Patients already enrolled or clinically reviewed following a relapse
- Patients with several prostheses requiring at least two revisions during the same surgical procedure
- Patients for whom the microbiologist and/or doctor responsible for the care refuses that these patients participate in the study
- HIV+ patients
- Patients undergoing chemotherapy for a blood disease or solid tumour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of test BJI 2
Time frame: 2 years
The diagnostic performance of the test during unique titration. * Sensitivity: estimated from the proportion of septic group patients with an antibody level above the defined threshold antibody concentration. * Specificity: estimated from the proportion of non-septic-group patients with an antibody level less than or equal to the defined threshold antibody concentration. * Positive likelihood ratio. * Negative likelihood ratio.
1 secondary outcome
Interest of test BJI 2
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
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.
2 sites 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 Prosthetic Infections, run by Diaxonhit at 2 sites 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 5 inclusion and 7 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 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Sensitivity and specificity of test BJI 2 (time frame: 2 years). 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 21 Aug 2014; AzTrials last refreshed its copy on 8 Nov 2026.