ADenoVirus Initiative Study in Epidemiology

• Research type

  Research Study

• Full title

  Epidemiological, Prospective, Multicentric, Open Study To Assess The Characteristics And Frequency Of Adenoviral Conjunctivitis As Diagnosed With The Point Of Care AdenoPlus® Test In Patients Suffering From Acute Conjunctivitis

• IRAS ID

  129769

• Contact name

  Brigitte Duquesroix

• Contact email

  duquesroix@nicox.com

• Sponsor organisation

  Nicox Pharma

• Clinicaltrials.gov Identifier

  NCT02112773, Clinicaltrial.gov

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  This is a non-interventional open, multicentre, observational study, collecting data from patients suffering from Acute Conjunctivitis and who have a point of care in vitro diagnostic test AdenoPlus® performed to diagnose the cause of their conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization.
  AdenoPlus® Test is part of the routine clinical care in UK for patients with conjunctivitis; although it is not systematically used by the ophthalmologists the AdenoPlus®test will be mandatory in the ADVISE study to confirm/infirm their clinical diagnosis. The AdenoPlus® Test is an In Vitro Diagnostic Medical Device that is CE marked in the UK and this test is currently used in hospital and private practices, helping differential diagnosis in patients with conjunctivitis.
  This epidemiological study will include approximately 500 patients recruited in approximately 10 sites in the England.
  Data from the patients will be recorded on a specific electronic questionnaire with the main objectives to assess the frequency of patients with adenovirus conjunctivitis as diagnosed with AdenoPlus® test, to better define the patient’s profiles with positive and negative AdenoPlus® test results (i.e. eyes signs and symptoms, duration of the disease) and the correlation between the initial clinical diagnosis (before AdenoPlus® test results) and the final diagnosis (post AdenoPlus® test results) in a population of male and female patients who present signs and symptoms of acute conjunctivitis. Pharmacoeconomic endpoints have also been included (absenteeism, pre-and post-diagnosis prescribed treatments).

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  14/LO/1969

• Date of REC Opinion

  17 Nov 2014

• REC opinion

  Further Information Favourable Opinion