Reducing Adeno-Viral Patient Infected Days: Secondary Analyses

减少腺病毒患者感染天数：二次分析

• 批准号: 9809154
• 负责人: MAE O GORDON
• 金额: $ 23.56万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9809154
• 关键词: 16S ribosomal RNA sequencing; Address; Adenoviruses; Artificial Tears; Clinical; Clinical Trials; Collection; Conjunctivitis; Data; Data Analyses; Data Set; Diagnosis; Economics; Epidemic; Event; Eye; Eye Infections; FDA approved; Funding; Grant; IL8 gene; Immunoassay; Infection; Manuscripts; Masks; Metagenomics; Methods; Modeling; Monitor; Participant; Patient Self-Report; Patients; Povidone-Iodine; Primary Care Physician; Primary Health Care; Public Health; Publications; Randomized; Reporting; Review Committee; Safety; Sampling; Secure; Severities; Signs and Symptoms; Swab; Symptoms; Testing; Universities; Visit; Washington; Work; base; clinical Diagnosis; clinical phenotype; diagnostic accuracy; economic impact; efficacy study; improved; innovation; next generation sequencing; ocular microbiome; phenotypic data; predictive modeling; primary caregiver; screening; secondary analysis; symptomatology; transmission process; trial comparing

Project Summary In the 21st century, adenoviral conjunctivitis (Ad-Cs) continues to be an eye infection of epidemic potential that can cause marked symptomatology, work-flow stoppages and significant economic losses. There is no FDA approved treatment for adenoviral conjunctivitis. A treatment that reduces the 5-12 day period of transmission and/or infection even by a few days would have significant public health and economic impact. “Reducing Adenoviral Patient-Infected Days” (RAPID), is a double-masked, randomized planning study of the efficacy of an in-office administration of 5% povidone iodine (PVP-I) compared to artificial tears to reduce duration and severity of Ad-Cs. Data collected at each visit include patient self-reported symptoms, clinical signs and conjunctival swab taken for adenoviral qPCR, IL-8, 16S amplicon sequencing. Of the 212 participants who were successfully screened, 56 tested positive for adenovirus by immunoassay and were randomized to receive either 5% PVP-I or artificial tears. Post-randomization visit completion rates at 1-2 days, 4, 7, 14 and 21 days were 88%, 75%, 79%, 63% and 68% respectively. The Data and Safety Monitoring Committee reviewed final results September 18, 2019 and recommended analysis/publication of several secondary analyses. Cross-sectional data for participants presenting with “pink eye” and longitudinal data for randomized participants provide an unprecedented opportunity to examine relationships between phenotypic data, 16S amplicon sequencing, qPCR and IL-8 (Aim A). Screening data from patient self-report and clinical signs provide strong evidence that a multivariate clinical prediction model could be developed to improve diagnostic accuracy of Ad-Cs in primary care practices where most patients with “pink eye” seek treatment (Aim B). All data reside in secure, de-identified datasets at the Washington University in St. Louis Coordinating Center ready for secondary analyses. This R-21 Secondary Analysis grant will support analysis, submission and publication of manuscripts from these 2 broad Aims within the 24 month funding period.

项目摘要 进入世纪，腺病毒性结膜炎（Ad-Cs）仍是眼部感染的流行病 可能导致明显的脑血管病、工作流程中断和严重的 经济损失没有FDA批准的治疗腺病毒结膜炎。治疗 将5-12天的传播和/或感染期缩短几天， 对公众健康和经济产生重大影响。 “减少腺病毒患者感染天数”（RAPID）是一项双盲、随机 5%聚维酮碘（PVP-I）诊室给药有效性的计划研究 与人工泪液相比，减少Ad-Cs的持续时间和严重程度。数据收集在每个 访视包括患者自我报告的症状、临床体征和结膜拭子， 腺病毒qPCR、IL-8、16 S扩增子测序。在212名参与者中， 成功筛选后，56名腺病毒免疫检测呈阳性，并随机 接受5% PVP-I或人工泪液。1-2时随机化后访视完成率 4d、7 d、14 d和21 d的治愈率分别为88%、75%、79%、63%和68%。 数据和安全监测委员会于2019年9月18日审查了最终结果， 推荐的分析/发表了几项二次分析。横截面数据 呈现“红眼病”的参与者和随机化参与者的纵向数据提供了 这是一个前所未有的机会，可以检查表型数据、16 S扩增子 测序、qPCR和IL-8（Aim A）。来自患者自我报告和临床体征的筛选数据 提供了强有力的证据，表明可以开发多变量临床预测模型， 在初级保健实践中提高Ad-Cs诊断准确性， 眼睛”寻求治疗（目标B）。所有数据都存储在华盛顿的安全、去识别数据集中 圣路易斯大学协调中心准备进行二次分析。R-21中学 分析补助金将支持分析，提交和出版这两个手稿 在24个月的融资期内实现广泛目标。