ADenoVirus Initiative Study in Epidemiology in Germany

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

The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

Study Overview

• Status: Completed
• Conditions: Viral Conjunctivitis

Detailed Description

Epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. This epidemiological study will include approximately 500 patients in Germany. The planned duration of the study is one year from the first patient visit to the last patient visit.

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Uwe Pleyer
  • Freiburg, Germany, 79106
    • University eye hospital Freiburg
  • Hannover, Germany, 30625
    • Florian Seidensticker
  • Heidelberg, Germany, 69121
    • Dr. Thomas Kaercher
  • Karlsruhe, Germany, 76131
    • Dr. Michael Hyppa
  • Karlsruhe, Germany, 76133
    • Städtisches Klinikum Karlsruhe Augenklinik
  • Karlsruhe, Germany, 76229
    • Karlheinz Krüger
  • Kiel, Germany, 24105
    • Stefan Koinzer
  • Köln, Germany, 50937
    • Poliklinik Leiter
  • Mainz, Germany, 55131
    • Katrin Lorenz
  • München, Germany, 80336
    • Klinikum der Universität München
  • Münster, Germany, 48143
    • Ulrich Thelen
  • Prien a. Chiemsee, Germany, 83209
    • Ines Lanzl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any female and male patients from one year of age with signs and symptoms of acute conjunctivitis either seen during ophthalmology consultations or who are in the emergency room or hospitalized, can be enrolled in the study

Description

Inclusion Criteria:

• Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms.
• Patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data.
• No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components).

Exclusion Criteria:

• Current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result.
• Previous enrolment in the present study.
• Any direct involvement with the study conduct at site or any family link with study site staff.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of patients with adenovirus conjunctivitis	The percentage of patients with adenovirus conjunctivitis documented by a positive AdenoPlus® test over the tested population of male and female patients who present signs and symptoms of acute conjunctivitis.	During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seasonality and geographic repartition observed.	The number of patients with adenovirus conjunctivitis who visited the ophthalmologist in spring, summer, autumn and winter and their geographic area (e.g. by hospital, by area).	During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
Clinical profiles of the patients	The percentage of each eye signs and symptoms, the mean duration of the disease for both the patients with positive and negative AdenoPlus® tests, the number or follow-up visit done and the correlation between the initial diagnosis (before AdenoPlus® test results) and the final diagnosis (post AdenoPlus® test results).	During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
Resource utilization during the treatment and evaluation of the costs	Estimation of resource utilized during course of treatment (use of drugs, number of visits done by the patient…), and associated costs (which would be calculated by applying unit costs to resource use).	On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s)
Patient/parent absenteeism linked to this disease.	Number of days out of work and/or out of school linked to this disease.	On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s)
Safety assessment	Number of adverse incidents (AIs) and events that are of significant (SEs) reported to Nicox	On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s)

Collaborators and Investigators

• Sponsor: NicOx
• Investigators: Principal Investigator: Elizabeth M Messmer, MD, University Hospital Munich

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: February 3, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 10, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Eye Diseases; Conjunctival Diseases; Eye Infections; Eye Infections, Viral; Conjunctivitis; Conjunctivitis, Viral
• Other Study ID Numbers: ADVISE Germany

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED