ADVISE (ADenoVirus Initiative Study in Epidemiology)

Abstract

AbstractPurpose ADVISE is an epidemiological, prospective, multicentric, open study to assess the characteristics and frequency of adenoviral conjunctivitis (AC) as diagnosed with the point of care AdenoPlus® test in patients suffering from acute conjunctivitis in 5 EU countries (F, It, Ger, UK, Sp).Methods Bacterial or viral conjunctivitis are usually self‐limiting but some viral cases may cause persistent disease and significant morbidity. AC causes more severe disease, is extremely contagious (transmission rate 10‐50%), of longer duration than bacterial (shed for 14‐16 days, signs and symptoms last 2‐3 weeks) and may lead to decreased visual acuity or light sensitivity from persistent subepithelial infiltrates, chronic dry eye, and visual loss from conjunctival scarring.Results AdenoPlus® is a single use, rapid (10 min.) immunoassay test for the qualitative in‐vitro detection of Adenoviral hexon protein antigens directly from human eye fluid. It is a CE marked, point‐of‐care medical device intended for health professional use as an aid in the rapid differential diagnosis of acute conjunctivitis. Study objectives are to assess the % of patients with acute conjunctivitis who have AC, the clinical profiles associated with positive and negative tests, the correlation between the initial clinical diagnosis and the final diagnosis (post‐test), the AC seasonality and geographic distribution, and to collect pharmacoeconomic data (before/after test prescribed treatments, work/school absenteeism…).Conclusion Enrollment started in June 2013 in France and in January 2014 in Germany. Italian, Spanish and UK sites will start recruiting Q2‐Q3/2014. Approximately 2500 patients are expected across EU, 500 patients from 15‐20 sites per country (20‐30 patients per site). The first interim study results will be presented with data analyses from at least 400 patients recruited in EU.