Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 442
- 试验地点
- 2
- 主要终点
- Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio.
研究概览
简要总结
Infectious keratitis are favored by the circumstances causing the small trauma of the corneal epithelium, corneal surgery, corneal dryness under health system such as Sjögren's syndrome rheumatoid arthritis, or much more frequently wearing contact lenses. If the majority of infectious keratitis are favourable, some lead to serious injury of the cornea, or even corneal perforation which result an endophthalmitis. This unfavourable evolution may lead to blindness due to corneal damage, the endo-ocular lesions or enucleation of the eyeball. This negative evolution is encountered while the infectious keratitis due to tedious germs of difficult diagnosis such as nontuberculous Mycobacterial, fungal infections, fungal keratitis, amoebic keratitis, and certain viral keratitis. The microbiological diagnosis of routine is based on the systematic search for pathogens tedious from invasive sampling of cornea by vaccinostyle. We set up a new non-invasive corneal swab diagnostic method.
详细描述
Primary Purpose: Compare the ability diagnostic of non-invasive sampling swab corneal versus the gold standard, (invasive vaccinostyle uptake) for the systematic search for pathogens tedious in corneal specimens.
Hypothesis
The diagnostic strategy using a microbial testing of cornea method has a sensitivity of 90% and a specificity of 80% or more over the policy diagnostic using a sampling by vaccinostyle method.
Primary outcome measures: Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Patient is more than 18 years old.
- •Patient with a prescription of a microbiologic diagnostic of keratitis
- •Patient who do not declined to have his medical records reviewed for research
- •Patient with health insurance
排除标准
- •minor patient (<18 years).
- •Pregnant or breastfeeding women.
- •Major Patient under guardianship.
- •Patient in vital emergency.
- •Private Patient liberty or under court order.
- •Patient refusing to sign the informed consent form
结局指标
主要结局
Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio.
时间窗: 1 day
次要结局
未报告次要终点