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.
Secondary analyses of data from a clinical trial that compared 5% povidone iodine to artificial tears for adenoviral conjunctivitis. Aim A examines cross-sectional and longitudinal relationships of patient-reported symptoms, clinical signs, qPCR, IL-8 and 16S sequencing of conjunctival samples at screening/baseline, 1-2, 4, 7, 14 and 21 days. Aim B develops a clinical prediction model for primary caregivers for the diagnosis of Ad-Cs.
