NCT00266734已完成不适用
A Prospective Blinded Multi-center Clinical Trial to Evaluate the Efficacy of the Recently FDA Approved RPS Adeno Detector for Detecting Adenoviral Conjunctivitis
Rapid Pathogen Screening6 个研究点 分布在 2 个国家目标入组 186 人开始时间: 2004年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 6
- 主要终点
- Ability to accurately detect presence or absence of adenovirus in conjunctival specimens
研究概览
简要总结
To compare the efficacy of a recently FDA approved point of care diagnostic test, the RPS Adeno Detector (Rapid Pathogen Screening, Inc.; South Williamsport, PA), against cell culture for detecting adenoviral conjunctivitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single
入排标准
- 年龄范围
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Study Enrollment Criteria
- •Upon completing the in-vitro studies, a perspective, blinded clinical study was started. Patients who were older than 1 month of age, seen within 7 days of developing a red eye, and who demonstrate at least one criterion from two out of the three categories below were included:
- •I. History: 1) Spread from one eye to the other several days later, 2) recent or concurrent upper respiratory symptoms within the preceding two weeks, 3) or an exposure to someone with "pink eye" within the preceding three weeks
- •II. Symptoms: 1) Tearing, 2) mucoid or purulent discharge, 3) eye lash matting, 4) burning, 5) itching, or 6) foreign body sensation
- •III. Signs: 1) An inferior palpebral conjunctival reaction with > or = 1+ papillary or follicular reactions, 2) presence of a preauricular node
排除标准
- •Patients with associated skin vesicles, corneal dendrites, traumatic corneal abrasion, concurrent corneal ulcers, foreign bodies, ocular pemphigoid, trauma, previous history of chemical/thermal injury to eyes or eyelids (anytime in past), or greater than trace intraocular inflammation were excluded from the study. Additionally, patients with allergy to corn starch, talcum powder, or dacron were also be excluded. Patients using any topical ophthalmic medication (i.e. antibiotics) were required to wait at least 30 minutes from their last dose prior to device application and wait at least 2 hours after their last dose of any ointment application
结局指标
主要结局
Ability to accurately detect presence or absence of adenovirus in conjunctival specimens
次要结局
未报告次要终点
研究者
研究点 (6)
Loading locations...
相似试验
已完成
3 期
A Prospective Clinical Trial to Evaluate the Efficacy and Safety of Neurotropic B-Vitamins in Clinically Diagnosed Peripheral Sensory Polyneuropathy of Different Etiologies.Peripheral Sensory Neuropathy of Different EtiologiesNCT05619328Procter and Gamble323
已完成
不适用
Diagnostic Accuracy of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric PatientsFeverRespiratory Tract InfectionsNCT03052088MeMed Diagnostics Ltd.1,140
已完成
不适用
Added Value of Cone Beam CT Guidance to Electromagnetic Navigation Bronchoscopy for the Diagnosis of Pulmonary Nodule.Pulmonary DiseaseLung CancerNCT05257382Erasme University Hospital49
已完成
不适用
Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POCCOVID-19 Virus InfectionCOVID-19Coronavirus Disease-19COVID-19 PandemicSARS-CoV-2 InfectionNCT05514691bioLytical Laboratories129
已完成
3 期
MK0653A (Ezetimibe (+) Simvastatin) Compared to an Approved Drug (Atorvastatin) for the Treatment of High Cholesterol (0653A-051)(COMPLETED)HypercholesterolemiaNCT00092690Organon and Co1,902