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
在21世纪,腺病毒结膜炎(Ad-Cs)仍是眼部感染的流行
可能会导致明显的症状、工作流程中断和显著
经济损失。目前还没有FDA批准的对腺病毒结膜炎的治疗方法。一种治疗
这将减少5-12天的传播和/或感染时间,即使是几天也会
对公共卫生和经济有重大影响。
《减少腺病毒患者感染天数》(RAPID),是一个双掩蔽、随机的
办公室注射5%聚维酮碘(PVP-I)疗效的计划研究
与人工泪液相比,可减少Ad-Cs的持续时间和严重程度。在每个站点收集的数据
访视内容包括患者自述症状、临床体征和结膜拭子检查。
腺病毒定量聚合酶链式反应、白介素8、16S扩增序列测定。在212名参与者中,
成功筛查,56例腺病毒免疫检测呈阳性,并被随机
接受5%PVP-I或人工泪液。随机化后的访问完成率为1-2
第4、7、14、21天分别为88%、75%、79%、63%、68%。
数据和安全监测委员会审查了2019年9月18日的最终结果,并
建议的分析/出版几个二次分析。的横截面数据
为随机参与者提供“粉红眼”和纵向数据的参与者提供
一个前所未有的机会来研究表型数据、16S扩增子之间的关系
测序、定量聚合酶链式反应和白介素8(目标A)。从患者自我报告和临床体征中筛选数据
提供了强有力的证据,表明多变量临床预测模型可以开发成
在初级保健实践中提高Ad-Cs的诊断准确性,在这些实践中,大多数“粉红色”患者
眼睛“寻求治疗(目标B)。所有数据都驻留在华盛顿的安全的、未识别的数据集中
圣路易斯大学协调中心准备进行二次分析。这所R-21中学
分析补助金将支持分析、提交和出版这两个项目的手稿
广泛的目标是在24个月的资助期内。
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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