REDUCING ADENOVIRAL PATIENT-INFECTED DAYS (RAPID)

减少腺病毒患者感染天数（快速）

• 批准号: 9001335
• 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 2020-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9001335
• 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; Health Insurance; Hour; Immune; Infection prevention; Influentials; Japan; Label; Local Anti-Infective Agents; Manuals; Masks; Minority; Multi-Institutional Clinical Trial; Operative Surgical Procedures; Outcome; Patient-Focused Outcomes; Patients; Povidone-Iodine; Preparation; Procedures; Provider; Public Health; Publishing; Randomized; Randomized Clinical Trials; 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; ineffective therapies; meetings; rate of change; retention rate; standard care; symptomatic improvement; 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（由申请人提供）：腺病毒结膜炎 (Ad-Cs) 是一种常见疾病，占全科医生执业的 2%，具有传染性，并且由于某些腺病毒血清型的流行潜力，具有相当大的经济影响。在德国和日本，Ad-Cs 是一种需要报告的疾病，估计每年在急性结膜炎的治疗上花费 6.7 亿美元，而患者却漏诊。平均工作或上学五天（范围 2-10），即使是减少患者症状或传染两天或三天的治疗也会对公共健康和经济产生重大影响 目前尚无 FDA 批准的针对 Ad-C 的治疗方法。 Ad-C 的理想治疗方法是安全、有效、低成本且可广泛使用，PVP-I 具有广谱抗菌功效和出色的“标签外安全性”。 “ 使用验光和眼科界有影响力的社论和评论提倡使用 PVP-I 治疗 Ad-Cs，但不幸的是，PVP-I 用于治疗的研究很少。随着 PVP-I 治疗 Ad-C 的超说明书使用的增加，确定性研究的紧迫性也随之增加，这将影响确定性研究的结果。 无论 PVP-I 是否有效，临床实践中的任何一个结果都将为决定此类治疗是否应纳入健康保险计划提供合理的基础。进行一项明确的随机临床试验，评估在办公室内使用单次 5% PVP-I 是否比使用人工泪液的标准治疗更有效地减少 Ad-C 患者的病毒载量和改善症状。本规划研究的目的“减少腺病毒患者感染天数”(RAPID) 旨在为国家多中心临床试验提供关键规划参数，以明确检验这一假设。