Performances of DendrisCHIP®OA in Bone and Joint Infections

NCT06132347 | Withdrawn

• 1 other identifier: ARX-DENDRIS
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Bone Infection; Joint Infection; Molecular Diagnostic

Keywords

Bone and joint infection; Molecular diagnostic

Outcome Measures

Primary Outcomes (1)

• 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).

  at 6 months

Secondary Outcomes (4)

• Document discrepancies using alternative techniques (specific PCR, sequencing)

  through study completion, an average of 6 months

• Difference of delay

  at 6 months

• Impact evaluation of antibiotic therapy

  at 6 months

• Performance evaluation on a subgroup

  at the end of study, in an average of 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Officials

• Anne-Laure Roux, PharmD, PhD

  Laboratory of microbiology, Ambroise Paré hospital - APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 15, 2023
• Study Start: December 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 15, 2025

Record last verified: 2025-06