Epidemiological, Prospective, Multicentric, Open Study To Assess The Characteristics And Frequency Of Adenoviral Conjunctivitis As Diagnosed With The Point Of Care AdenoPlus® Test In Patients Suffering From Acute Conjunctivitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NicOx
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Frequency of patients with adenovirus conjunctivitis
研究概览
简要总结
The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.
详细描述
Epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. This epidemiological study will include approximately 500 patients in Italy. The planned duration of the study is one year from the first patient visit to the last patient visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms.
- •Patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data.
- •No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components).
排除标准
- •Current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result.
- •Previous enrolment in the present study.
- •Any direct involvement with the study conduct at site or any family link with study site staff.
结局指标
主要结局
Frequency of patients with adenovirus conjunctivitis
时间窗: During the visit to the ophthalmologist (one visit)
The percentage of patients with adenovirus conjunctivitis documented by a positive AdenoPlus® test over the tested population of male and female patients who present signs and symptoms of acute conjunctivitis.
次要结局
未报告次要终点