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:
  • 金额:
    $ 23.56万
  • 依托单位:
  • 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

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。

项目成果

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MAE O GORDON其他文献

MAE O GORDON的其他文献

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{{ truncateString('MAE O GORDON', 18)}}的其他基金

Long-Term Quality of Life in the Ocular Hypertension Treatment Study Cohort
高眼压治疗研究队列的长期生活质量
  • 批准号:
    10667711
  • 财政年份:
    2023
  • 资助金额:
    $ 23.56万
  • 项目类别:
Resubmission: Latent Class Trajectory Analysis in the OHTS Study
重新提交:OHTS 研究中的潜在类别轨迹分析
  • 批准号:
    10675764
  • 财政年份:
    2022
  • 资助金额:
    $ 23.56万
  • 项目类别:
Resubmission: Latent Class Trajectory Analysis in the OHTS Study
重新提交:OHTS 研究中的潜在类别轨迹分析
  • 批准号:
    10540153
  • 财政年份:
    2022
  • 资助金额:
    $ 23.56万
  • 项目类别:
Innovative Analytical Methods for Repeated Measures in the OHTS Study
OHTS 研究中重复测量的创新分析方法
  • 批准号:
    10219276
  • 财政年份:
    2020
  • 资助金额:
    $ 23.56万
  • 项目类别:
Ocular Hypertension Treatment Study 20-Year Follow-up: Clinical Center Grant
高眼压治疗研究 20 年随访:临床中心资助
  • 批准号:
    9316638
  • 财政年份:
    2015
  • 资助金额:
    $ 23.56万
  • 项目类别:
REDUCING ADENOVIRAL PATIENT-INFECTED DAYS (RAPID)
减少腺病毒患者感染天数(快速)
  • 批准号:
    8824082
  • 财政年份:
    2015
  • 资助金额:
    $ 23.56万
  • 项目类别:
Ocular Hypertension Treatment Study 20-Year Follow-up: Clinical Center Grant
高眼压治疗研究 20 年随访:临床中心资助
  • 批准号:
    9755439
  • 财政年份:
    2015
  • 资助金额:
    $ 23.56万
  • 项目类别:
Ocular Hypertension Treatment Study 20-Year Follow-up: Coordinating Center Grant
高眼压治疗研究 20 年随访:协调中心拨款
  • 批准号:
    9755440
  • 财政年份:
    2015
  • 资助金额:
    $ 23.56万
  • 项目类别:
Ocular Hypertension Treatment Study 20-Year Follow-up: Coordinating Center Grant
高眼压治疗研究 20 年随访:协调中心拨款
  • 批准号:
    9316636
  • 财政年份:
    2015
  • 资助金额:
    $ 23.56万
  • 项目类别:
REDUCING ADENOVIRAL PATIENT-INFECTED DAYS (RAPID)
减少腺病毒患者感染天数(快速)
  • 批准号:
    9543746
  • 财政年份:
    2015
  • 资助金额:
    $ 23.56万
  • 项目类别:

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