Contribution of Fast Molecular Bacterial Identification by Real-time PCR in Managing of Postoperative Acute Endophthalmitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Visual acuteness
研究概览
简要总结
Endophthalmitis is a serious eye infection of exogenous origin (post-operational, post-traumatic) or endogenous origin (metastatic). This is a diagnostic and therapeutic emergency.
Each patient suffering from endophthalmitis must have immediately an ocular sampling, an intra ocular injection of antibiotics and a systemic antibiotic cover.
The etiological treatment will be adapted according to the infectious agent.
详细描述
The main goal of this prospective multi-centre trial is to improve the sensitivity and rapidity of the infectious agent's identification involved in endophthalmitis cases, particularly virulent species (like Staphylococcus aureus, Streptococcus pneumoniae...) from ocular samples with the help of real-time PCR.
This will help the ophthalmologist to be more efficient in accordance with the kind of the bacteria.
Data will also enable to compare both PCR techniques used in this study. The secondary goal of the prospective study is to characterize the resistance of bacterial's species found during acute endophthalmitis with the antibiogram and by the study of resistance genes, to enable to correlate the resistance in vitro with the therapeutic response in vivo and get precious epidemiological data to adapt prophylactic antibiotic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects affiliated to the social security system
- •Signed informed consent documentation
- •Patients over 18 years
- •Male or female person
- •Patients hospitalized for diagnostic and therapeutic evaluation of a post-operative acute endophthalmitis, or within the context of a scheduled surgery with sampling of aqueous humour.
- •Has given his or her consent, having been provided with detailed informations regarding to intraocular sampling.
排除标准
- •antibiotherapy via intravenous (< 8 days) for patients NON suffering from endophthalmitis (control group)
- •Patient's participation to the study refused
- •Patients under 18 years
- •Patients adults under guardianship or curatorship, or unable to express his/her consent.
- •Pregnant women
- •Breastfeeding women
- •Person deprived of liberty
结局指标
主要结局
Visual acuteness
时间窗: 2 minutes
Clinical follow-up of patients
Intraocular pressure
时间窗: 5 minutes
Clinical follow-up of patients
Biomicroscopic exam with the slit lamp
时间窗: 3 minutes
State of anterior and posterior segment (back of the eye)
次要结局
未报告次要终点