Complex Ocular Infection, Optimization of Microbiological Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Positivity rates of COI samples according to the new protocol
研究概览
简要总结
The purpose of this study is to evaluate the impact of different technique to optimize the microbiological diagnosis of the COI.
- Metagenomic for the endophtalmitis
- Multiplex polymerase chain reaction for corneal abscesses
详细描述
Microbiological diagnosis of complex ocular infection (COI) (i.e: endophtalmitis and corneal abscess) is a current challenge. Indeed, endophtalmitis are often germ-free because a lack of microbiological diagnosis due to small volume to analyze and a complex site to attain. The microbiological etiologies of corneal abscesses are more frequently identified.
Since few years, new molecular tools are developed in infectious diseases to optimizing the microbiological diagnosis. The investigators implemented these techniques in our hospital to optimize the microbiological diagnosis of complex ocular infection (COI). Thus, endophtalmitis benefit, when the volume of the ocular sample is sufficient, of molecular techniques (16s PCR and metagenomic shotgun). Corneal abscesses could shortly benefit of multiplex PCR in order to reduce the time to diagnosis.
The impact and accuracy of these techniques is unknown.
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
- •Adult patient
- •Patient presenting or having presented a clinical suspicion of complex ocular infection requiring a sample for microbiological diagnosis:
- •Corneal abscess requiring hospitalization
- •Any suspicion of endogenous or exogenous endophthalmitis.
- •Patient not opposed to participating in the research
排除标准
- •Patient under guardianship or curatorship
- •Pregnant women
结局指标
主要结局
Positivity rates of COI samples according to the new protocol
时间窗: 2 weeks after taking samples
Before/after type comparison. Comparison of the positivity rates of COI samples according to the new protocol: (i) for endophthalmitis performing a vitreous puncture (PV) or an anterior chamber puncture (PCA), or corneal scraping, optimized with modification of microbiological techniques (culture on enriched medium alone associated with shotgun metagenomics), (ii) for severe corneal abscesses, addition to standard microbiological techniques of molecular biology tests (multiplex PCR and / or metagenomics). An COI will be considered with a positive microbiological diagnosis after multidisciplinary concertation considering the different results
次要结局
- Modification or not of the anti-infectious treatment(At the end of the follow up: 18 months)
- Microbiological diagnosis of the infection(At the end of the follow up: 18 months)
- Time to microbiological diagnosis according to the different technic(At the end of the follow up: 18 months)
- Accuracy of the different technics according to the gold standard (microbiological culture)(At the end of the follow up: 18 months)
- Visual acuity(At the end of the follow up: 18 months)
- Cure rate(At the end of the follow up: 18 months)