ADenoVirus Initiative Study in Epidemiology in Germany

Viral Conjunctivitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054273
• Other study ID #: ADVISE Germany
• Status: Completed
• Phase: N/A
• First received: January 17, 2014
• Last updated: January 10, 2017
• Start date: April 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2017
• Source: NicOx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Viral
• Viral Conjunctivitis

Locations

Country	Name	City	State
Germany	Uwe Pleyer	Berlin
Germany	University eye hospital Freiburg	Freiburg
Germany	Florian Seidensticker	Hannover
Germany	Dr. Thomas Kaercher	Heidelberg
Germany	Dr. Michael Hyppa	Karlsruhe
Germany	Karlheinz Krüger	Karlsruhe
Germany	Städtisches Klinikum Karlsruhe Augenklinik	Karlsruhe
Germany	Stefan Koinzer	Kiel
Germany	Poliklinik Leiter	Köln
Germany	Katrin Lorenz	Mainz
Germany	Klinikum der Universität München	München
Germany	Ulrich Thelen	Münster
Germany	Ines Lanzl	Prien a. Chiemsee

Sponsors (1)

Lead Sponsor	Collaborator
NicOx

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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)