REDUCING ADENOVIRAL PATIENT-INFECTED DAYS (RAPID)

 描述（由申请人提供）：腺病毒结膜炎（Ad-Cs）是一种流行病，占全科医生执业的2%，具有高度传染性，并具有相当大的经济影响。由于某些腺病毒血清型的流行潜力，Ad-Cs在德国和日本是一种可报告的疾病。据估计，每年花费6.7亿美元用于急性结膜炎的管理，受影响的患者平均错过5天的工作或学校（范围2-10）。一种治疗方法，即使减少病人的症状或传染两三天，也会产生重大的公共卫生和经济影响。没有FDA批准的Ad-Cs治疗方法。Ad-Cs的理想治疗将是安全、有效、低成本和广泛可用的。聚维酮碘（PVP-I）符合这些标准。PVP-I具有广谱抗微生物有效性和优异的安全性。视光学和眼科领域内有影响力的社论和评论已经推动了PVP-I治疗Ad-Cs的“标签外”使用。相当少的临床医生报告使用PVP-I治疗Ad-Cs。不幸的是，PVP-I用于治疗Ad-Cs的研究是不受控制的、未掩蔽的和/或动力不足的。随着PVP-I治疗Ad-Cs的标签外使用的增加，确定性研究的紧迫性增加。一项明确的研究结果将影响 临床实践是否发现PVP-I有效。缺乏效果将使数十万人免于无效治疗。无论哪种结果，都将为决定这种治疗是否应纳入健康保险计划提供合理的依据。我们的长期目标是进行一项确定性的随机临床试验，评估在Ad-Cs患者中，单次在办公室应用5% PVP-I是否比人工泪液标准治疗更有效，以减少病毒负荷并改善症状。本计划研究“减少腺病毒患者感染天数”（RAPID）的具体目的是为国家多中心临床试验提供关键计划参数，以明确验证这一假设。

 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.