Bone InfectionDENDRISNCT06132347
Performances of DendrisCHIP®OA in Bone and Joint Infections
An observational study of Bone Infection and Joint Infection, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Bone and joint infections (BJI) with and without prosthetic material (knee, hip and shoulder) are complex to diagnose and treat, justifying the creation of expert centers by the French Ministry of Health (CRIOAc). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Infection, Joint Infection, Molecular Diagnostic
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to May 2024
- 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: All patients who had intraoperative samples for suspected BJI with or without material, and who received on broad-spectrum antibiotic therapy post-operatively.
Who may be able to join
- Patients aged ⩾ 18 years,
- Patients suspected of bone and joint infection,
- Any patient who had intraoperative samples for suspected BJI with or without material, and who received on broad-spectrum antibiotic therapy post-operatively,
- No opposition from the patient, or its surrounding.
Who cannot join
- Refusal to participate,
- Pregnant or beastfeeding,
- Patient under guardianship or curatorship,
- Patient not affiliated to social security,
- Patient affiliated to the Aide Médicale d'Etat (AME).
About this study
Bone and joint infections (BJI) with and without prosthetic material (knee, hip and shoulder) are complex to diagnose and treat, justifying the creation of expert centers by the French Ministry of Health (CRIOAc).
In case of BJI with material, the diagnosis is based on a set of clinical, bacteriological, cytological and radiological criteria known as the EBJIS 2021 (European Bone \& Joint Infections Society) criteria. For septic arthritis, diagnosis is based on bacteriology and cytology.
Read more
Microbiology remains essential, and the delay of obtention of microbiological results is crucial to adapt the antibiotic treatment. Although, culture-based microbiology remains the most common diagnosis of BJI, its regular failure to identify the causative pathogen as well as its long-term modus operandi motivates the development of rapid and accurate molecular methods.
The DendrisCHIP®OA platform has demonstrated its ability to offer routine molecular identification of the current micro-organisms involved in BJI, in less than 5 hours, with the detection of mecA resistance genes on series of 16 to 64 samples . The DendrisCHIP®OA is CE-marked and has already been the subject of an initial publication evaluating its performance in a single center.
The main objective of this study is to evaluate the diagnostic performances of the DendrisCHIP®OA in detecting the pathogens recognized in its panel and the detection of the mecA gene compared with the routine microbiological techniques used in the inclusion centers participating to the study.
The study aims to include 100 patients during 6 months in five inclusion centers in the Ile de France region.
Read the detailed description
Bone and joint infections (BJI) with and without prosthetic material (knee, hip and shoulder) are complex to diagnose and treat, justifying the creation of expert centers by the French Ministry of Health (CRIOAc).
In case of BJI with material, the diagnosis is based on a set of clinical, bacteriological, cytological and radiological criteria known as the EBJIS 2021 (European Bone \& Joint Infections Society) criteria. For septic arthritis, diagnosis is based on bacteriology and cytology.
Currently, a patient with suspected BJI remains hospitalized for at least 5 days with parenteral antibiotics, until the results of bacteriological culture. If the bacteriological diagnosis is negative, and the clinical suspicion of infection is weak, treatment is stopped at least 7 days post-operatively. If the microbiological diagnosis is positive, the choice of the therapeutic will depend on the isolated bacterial species. So, microbiology remains essential, and the delay of obtention of microbiological results is crucial to adapt the antibiotic treatment.
Microbiological culture techniques remain the gold standard, but are time-consuming (3 to 14 days), and require qualified personnel, with a risk of false negative results in 5 to 10% of cases (prior antibiotic therapy, atypical or fastidious microorganisms). These diagnostic limitations lead to care difficulties, with major consequences in terms of morbidity, quality of life and treatment costs.
Syndromic molecular methods (metagenomics, Unyvero Cartridges, Biofire® nested-PCR), which could improve microbiological diagnosis, are currently being evaluated, but have a number of drawbacks that make this tests as complementary methods in specialized laboratories (cost, productivity, insufficient panels, etc.).
The DendrisCHIP®OA platform has demonstrated its ability to offer routine molecular identification of the current micro-organisms involved in BJI, in less than 5 hours, with the detection of mecA resistance genes on series of 16 to 64 samples. The DendrisCHIP®OA is CE-marked and has already been the subject of an initial publication evaluating its performances in a single center.
On the other hand, the innovation brought by this technology is the analysis by artificial intelligence thanks to the DendriSOFT software, which takes into account biological variability. This database is constantly enhanced by self-learning.
The research will be carried out over a 6-months period to include 100 patients in five inclusion centers (CRIOAc) in Ile de France region, with a minimum of 2 patients treated for BJI per week per inclusion center.
The main objective of this study is to evaluate the diagnostic performances of the DendrisCHIP®OA in detecting the pathogens recognized in its panel and the detection of the mecA gene compared with the routine microbiological techniques used in the inclusion centers participating to the study.
The secondary objectives are :
- to document discrepancies using alternative techniques (specific PCR, sequencing)
- to compare turnaround times (from sampling to biological validation) between the routine microbiological technique and DendrisCHIP®OA
- to evaluate the impact on the patient's therapeutic management (modification of antibiotic treatment)
- to evaluate diagnostic performance of the DendrisCHIP®OA on a sub-group of culture-negative patients with clinical signs of infection.
- Conditions
- Bone Infection, Joint Infection, Molecular Diagnostic
- Keywords
- Bone and joint infection, Molecular diagnostic
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performances
Diagnostic performance of the DendrisCHIP®OA OA method in routine situation compared with the laboratory's usual method according to method validation criteria (sensitivity, specificity, NPV, PPV).
Measured: at 6 months
Secondary outcomes (4)
Document discrepancies using alternative techniques (specific PCR, sequencing)
Document discrepancies, in case of discrepancy between the DendrisCHIP®OA test result and the reference microbiological method.
The frozen sample is process for additional techniques (specific PCR or universal 16S PCR with sequencing).
Measured: through study completion, an average of 6 months
Difference of delay
Comparing of the delay between sampling date and date of biological validation, of DendrisCHIP®OA test and routine microbiological method.
Measured: at 6 months
Impact evaluation of antibiotic therapy
Duration of parenteral antibiotic therapy and time to adapt antibiotic treatment to microbiological documentation.
Measured: at 6 months
Performance evaluation on a subgroup
Determination of the sensitivity, specificity, PPV and NPV of the DendrisCHIP®OA method on a subgroup of patients negative with the routine microbiological technique but with clinical signs of infection.
Measured: at the end of study, in an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Why it stopped: The company that supplies the Medical Device has withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Laure Roux, PharmD, PhD, Principal investigator, Laboratory of microbiology, Ambroise Paré hospital - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132347
- Sponsor's protocol ID
- ARX-DENDRIS
- Acronym
- DENDRIS
- Status last verified
- Jun 2025
- First submitted
- 27 Oct 2023
- Last updated
- 15 Jun 2025
- 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 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performances of DendrisCHIP®OA in Bone and Joint Infections
- ClinicalTrials.gov ID
- NCT06132347
- Acronym / sponsor ID
- DENDRIS / ARX-DENDRIS
- Conditions
- Bone Infection, Joint Infection, Molecular Diagnostic
- Keywords
- Bone and joint infection, Molecular diagnostic
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The company that supplies the Medical Device has withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 15 Nov 2023 (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.
Bone and joint infections (BJI) with and without prosthetic material (knee, hip and shoulder) are complex to diagnose and treat, justifying the creation of expert centers by the French Ministry of Health (CRIOAc).
In case of BJI with material, the diagnosis is based on a set of clinical, bacteriological, cytological and radiological criteria known as the EBJIS 2021 (European Bone \& Joint Infections Society) criteria. For septic arthritis, diagnosis is based on bacteriology and cytology.
Microbiology remains essential, and the delay of obtention of microbiological results is crucial to adapt the antibiotic treatment. Although, culture-based microbiology remains the most common diagnosis of BJI, its regular failure to identify the causative pathogen as well as its long-term modus operandi motivates the development of rapid and accurate molecular methods.
The DendrisCHIP®OA platform has demonstrated its ability to offer routine molecular identification of the current micro-organisms involved in BJI, in less than 5 hours, with the detection of mecA resistance genes on series of 16 to 64 samples . The DendrisCHIP®OA is CE-marked and has already been the subject of an initial publication evaluating its performance in a single center.
The main objective of this study is to evaluate the diagnostic performances of the DendrisCHIP®OA in detecting the pathogens recognized in its panel and the detection of the mecA gene compared with the routine microbiological techniques used in the inclusion centers participating to the study.
The study aims to include 100 patients during 6 months in five inclusion centers in the Ile de France region.
Detailed description
Bone and joint infections (BJI) with and without prosthetic material (knee, hip and shoulder) are complex to diagnose and treat, justifying the creation of expert centers by the French Ministry of Health (CRIOAc).
In case of BJI with material, the diagnosis is based on a set of clinical, bacteriological, cytological and radiological criteria known as the EBJIS 2021 (European Bone \& Joint Infections Society) criteria. For septic arthritis, diagnosis is based on bacteriology and cytology.
Currently, a patient with suspected BJI remains hospitalized for at least 5 days with parenteral antibiotics, until the results of bacteriological culture. If the bacteriological diagnosis is negative, and the clinical suspicion of infection is weak, treatment is stopped at least 7 days post-operatively. If the microbiological diagnosis is positive, the choice of the therapeutic will depend on the isolated bacterial species. So, microbiology remains essential, and the delay of obtention of microbiological results is crucial to adapt the antibiotic treatment.
Microbiological culture techniques remain the gold standard, but are time-consuming (3 to 14 days), and require qualified personnel, with a risk of false negative results in 5 to 10% of cases (prior antibiotic therapy, atypical or fastidious microorganisms). These diagnostic limitations lead to care difficulties, with major consequences in terms of morbidity, quality of life and treatment costs.
Syndromic molecular methods (metagenomics, Unyvero Cartridges, Biofire® nested-PCR), which could improve microbiological diagnosis, are currently being evaluated, but have a number of drawbacks that make this tests as complementary methods in specialized laboratories (cost, productivity, insufficient panels, etc.).
The DendrisCHIP®OA platform has demonstrated its ability to offer routine molecular identification of the current micro-organisms involved in BJI, in less than 5 hours, with the detection of mecA resistance genes on series of 16 to 64 samples. The DendrisCHIP®OA is CE-marked and has already been the subject of an initial publication evaluating its performances in a single center.
On the other hand, the innovation brought by this technology is the analysis by artificial intelligence thanks to the DendriSOFT software, which takes into account biological variability. This database is constantly enhanced by self-learning.
The research will be carried out over a 6-months period to include 100 patients in five inclusion centers (CRIOAc) in Ile de France region, with a minimum of 2 patients treated for BJI per week per inclusion center.
The main objective of this study is to evaluate the diagnostic performances of the DendrisCHIP®OA in detecting the pathogens recognized in its panel and the detection of the mecA gene compared with the routine microbiological techniques used in the inclusion centers participating to the study.
The secondary objectives are :
- to document discrepancies using alternative techniques (specific PCR, sequencing)
- to compare turnaround times (from sampling to biological validation) between the routine microbiological technique and DendrisCHIP®OA
- to evaluate the impact on the patient's therapeutic management (modification of antibiotic treatment)
- to evaluate diagnostic performance of the DendrisCHIP®OA on a sub-group of culture-negative patients with clinical signs of infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had intraoperative samples for suspected BJI with or without material, and who received on broad-spectrum antibiotic therapy post-operatively.
Key inclusion criteria (4 listed)
- Patients aged ⩾ 18 years,
- Patients suspected of bone and joint infection,
- Any patient who had intraoperative samples for suspected BJI with or without material, and who received on broad-spectrum antibiotic therapy post-operatively,
- No opposition from the patient, or its surrounding.
Key exclusion criteria (5 listed)
- Refusal to participate,
- Pregnant or beastfeeding,
- Patient under guardianship or curatorship,
- Patient not affiliated to social security,
- Patient affiliated to the Aide Médicale d'Etat (AME).
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
Diagnostic performances
Time frame: at 6 months
Diagnostic performance of the DendrisCHIP®OA OA method in routine situation compared with the laboratory's usual method according to method validation criteria (sensitivity, specificity, NPV, PPV).
4 secondary outcomes
Document discrepancies using alternative techniques (specific PCR, sequencing)
Time frame: through study completion, an average of 6 months
Difference of delay
Time frame: at 6 months
Impact evaluation of antibiotic therapy
Time frame: at 6 months
Performance evaluation on a subgroup
Time frame: at the end of study, in an average of 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
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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.
Anne-Laure Roux, PharmD, PhD principal investigator
Laboratory of microbiology, Ambroise Paré hospital - APHP
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Infection and Joint Infection, run by Assistance Publique - Hôpitaux de Paris.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Diagnostic performances (time frame: at 6 months). 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 15 Jun 2025.