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Performances of DendrisCHIP®OA in Bone and Joint Infections

NCT06132347 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-06-15

No results posted yet for this study

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Anne-Laure Roux, PharmD, PhD · Laboratory of microbiology, Ambroise Paré hospital - APHP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2024-05-31
Completion
2024-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06132347 on ClinicalTrials.gov