Reducing Adeno-Viral Patient Infected Days: Secondary Analyses

减少腺病毒患者感染天数：二次分析

基本信息

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
项目类别：
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

项目摘要

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.

项目概要进入21世纪，腺病毒性结膜炎（Ad-Cs）仍然是流行性眼部感染可能会导致明显的症状、工作流程中断和严重的后果没有 FDA 批准的腺病毒结膜炎治疗方法。减少 5-12 天的传播和/或感染期，甚至缩短几天具有重大的公共卫生和经济影响。 “减少腺病毒患者感染天数”（RAPID）是一项双盲随机试验办公室内使用 5% 聚维酮碘 (PVP-I) 效果的规划研究与人工泪液相比，可减少每次收集的 Ad-C 数据的持续时间和严重程度。就诊包括患者自我报告的症状、临床体征和结膜拭子检查对 212 名参与者进行了腺病毒 qPCR、IL-8、16S 扩增子测序。成功筛查，56 例通过免疫测定检测腺病毒呈阳性，并被随机分组接受 5% PVP-I 或人工泪液随机化后访视完成率为 1-2。第 4 天、第 7 天、第 14 天和第 21 天分别为 88%、75%、79%、63% 和 68%。数据和安全监测委员会于2019年9月18日审查了最终结果并建议分析/发布一些二次分析的数据。以“红眼”呈现并提供纵向数据一个前所未有的机会来检查表型数据、16S 扩增子之间的关系测序、qPCR 和 IL-8（目标 A）从患者自我报告和临床体征中筛选数据。提供强有力的证据表明可以开发多变量临床预测模型提高初级保健实践中 Ad-C 的诊断准确性，其中大多数患者患有“粉红色” 眼睛”寻求治疗（目标 B）。圣路易斯大学协调中心已准备好对该 R-21 中学进行二次分析。分析补助金将支持这 2 名作者的手稿的分析、提交和出版 24 个月资助期内的广泛目标。