Performances of DendrisCHIP®OA in Bone and Joint Infections
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 主要终点
- Diagnostic performances
研究概览
简要总结
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.
详细描述
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.).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Diagnostic performances
时间窗: 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).
次要结局
- Document discrepancies using alternative techniques (specific PCR, sequencing)(through study completion, an average of 6 months)
- Performance evaluation on a subgroup(at the end of study, in an average of 6 months)
- Difference of delay(at 6 months)
- Impact evaluation of antibiotic therapy(at 6 months)