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
- 来源:
- 关键词:16S ribosomal RNA sequencingAddressAdenovirusesArtificial TearsClinicalClinical TrialsCollectionConjunctivitisDataData AnalysesData SetDiagnosisEconomicsEpidemicEventEyeEye InfectionsFDA approvedFundingGrantIL8 geneImmunoassayInfectionManuscriptsMasksMetagenomicsMethodsModelingMonitorParticipantPatient Self-ReportPatientsPovidone-IodinePrimary Care PhysicianPrimary Health CarePublic HealthPublicationsRandomizedReportingReview CommitteeSafetySamplingSecureSeveritiesSigns and SymptomsSwabSymptomsTestingUniversitiesVisitWashingtonWorkbaseclinical Diagnosisclinical phenotypediagnostic accuracyeconomic impactefficacy studyimprovedinnovationnext generation sequencingocular microbiomephenotypic datapredictive modelingprimary caregiverscreeningsecondary analysissymptomatologytransmission processtrial 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
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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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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