REDUCING ADENOVIRAL PATIENT-INFECTED DAYS (RAPID)

减少腺病毒患者感染天数（快速）

• 批准号: 8824082
• 负责人: MAE O GORDON
• 金额: $ 22.88万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-02-01 至 2017-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8824082
• 关键词: Acute Conjunctivitis; Address; Adenoviruses; Adoption; Advocate; Affect; Artificial Tears; Award; Caring; Clinical; Clinical Management; Clinical Practice Patterns; Clinical Trials; Communities; Conjunctivitis; Control Groups; Data; Detection; Development; Devices; Diagnosis; Economics; Effectiveness; Eligibility Determination; Epidemic; Eye; Eye Infections; FDA approved; Feasibility Studies; Funding; Future; General Practitioners; Germany; Goals; Gold; Grant; Health Insurance; Hour; Immune; Infection prevention; Influentials; Japan; Label; Local Anti-Infective Agents; Manuals; Masks; Minority; Multi-Institutional Clinical Trial; Operative Surgical Procedures; Outcome; Patients; Povidone-Iodine; Preparation; Procedures; Provider; Public Health; Publishing; Randomized; Randomized Clinical Trials; Relative (related person); Reporting; Safety; Sample Size; Schools; Serotyping; Signs and Symptoms; Site; Specificity; Symptoms; System; Techniques; Testing; Time; Treatment Efficacy; Viral Load result; Visit; Visual; Work; analog; antimicrobial; base; clinical Diagnosis; clinical practice; contagion; cost; design; detector; economic impact; editorial; follow-up; health economics; improved; meetings; public health relevance; standard care; viral resistance

 DESCRIPTION (provided by applicant): Adenoviral conjunctivitis (Ad-Cs) is a prevalent condition comprising as much as 2% of a general practitioner's practice, is highly contagious, and has considerable economic impact. Because of the epidemic potential of some adenoviral serotypes, Ad-Cs is a reportable condition in Germany and Japan. An estimated $670 million is spent annually on the management of acute conjunctivitis, and afflicted patients miss on average five days of work or school (range 2-10). A treatment that reduces patient symptoms or contagion by even two or three days would have significant public health and economic impact. There are no FDA-approved treatments for Ad-Cs. The ideal treatment for Ad-Cs would be safe, effective, low- cost and widely accessible. Povidone iodine (PVP-I) meets these criteria. PVP-I has broad- spectrum antimicrobial effectiveness and an excellent safety profile. "Off-label" use of PVP-I to treat Ad-Cs has been promoted by influential editorials and reviews within the optometric and ophthalmological communities. A significant minority of clinicians report using PVP-I to treat Ad- Cs. Unfortunately, studies of PVP-I for the treatment of Ad-Cs have been uncontrolled, unmasked and/or underpowered. The urgency for a definitive study has increased with the growing off-label use of PVP-I to treat Ad-Cs. Results from a definitive study will affect clinical practice whether PVP-I is found effective or not. Absence of effect would spare hundreds of thousands from ineffective treatment. Either result would provide a rational basis for deciding whether such treatment should be covered in health insurance plans. Our long-term goal is to conduct a definitive, randomized clinical trial that evaluates whether or not a single, in-office application of 5% PVP-I is more effective than standard care with artificial tears at reducing vira load and improving symptoms in patients with Ad-Cs. The specific aims of this planning study "Reducing Adenoviral Patient-Infected Days" (RAPID) is to provide key planning parameters for a national, multi-site clinical trial to test this hypothesis definitively.

 描述（由适用提供）：腺病毒结膜炎（AD-CS）是一种普遍的疾病，占总实践者实践的2％，具有高度传染性，并且具有经济影响。由于某些腺病毒血清型的流行潜力，AD-CS是德国和日本的可报告状况。估计每年花费6.7亿美元用于治疗急性结膜炎，折磨患者平均失踪了五天的工作或学校（2-10范围）。将患者症状或传染减少两到三天的治疗方法将对公共卫生和经济影响产生重大影响。 AD-CS没有FDA批准的治疗方法。 AD-CS的理想治疗方法是安全，有效，低成本且易于使用的。 Povidone碘（PVP-I）符合这些标准。 PVP-I具有广泛的抗菌效果和出色的安全性。在验光和眼科群落中，有影响力的社论和评论促进了对PVP-I治疗AD-CS的“非标签”。少数临床医生报告使用PVP-I治疗AD-CS。不幸的是，对PVP-I治疗AD-CS的研究未受控制，揭露和/或功能不足。随着PVP-I对治疗AD-C的不断增长，确定性研究的紧迫性增加了。最终研究的结果将影响 是否发现PVP-I有效。缺乏效果将使成千上万的治疗无效。两种结果将为确定是否应在健康保险计划中涵盖这种治疗方面提供合理的基础。我们的长期目标是进行一项确定的随机临床试验，该试验评估5％PVP-I的单一内办公室应用是否比标准护理更有效，在减少VIRA负载方面的人工泪液并改善了AD-CS患者的症状。这项计划研究的具体目的“减少腺病毒感染的日子”（快速）是为国家多站点临床试验提供关键的计划参数，以确切地检验该假设。