Clinical trial NCT02054273: ADenoVirus Initiative Study in Epidemiology in Germany
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Viral Conjunctivitis
Keywords: Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test
Lead sponsor: NicOx
Sponsor class: INDUSTRY
First posted: 2014-02-04
Enrollment: 240
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of patients with adenovirus conjunctivitis
timeFrame: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
Secondary outcomes:
Other outcomes:
measure: Seasonality and geographic repartition observed.
timeFrame: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
measure: Clinical profiles of the patients
timeFrame: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
measure: Resource utilization during the treatment and evaluation of the costs
timeFrame: On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s)
measure: Patient/parent absenteeism linked to this disease.
timeFrame: On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s)
measure: Safety assessment
timeFrame: On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s)
Locations:
city: Berlin
country: Germany
facility: Uwe Pleyer
city: Freiburg
country: Germany
facility: University eye hospital Freiburg
city: Hannover
country: Germany
facility: Florian Seidensticker
city: Heidelberg
country: Germany
facility: Dr. Thomas Kaercher
city: Karlsruhe
country: Germany
facility: Dr. Michael Hyppa
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe Augenklinik
city: Karlsruhe
country: Germany
facility: Karlheinz Krüger
city: Kiel
country: Germany
facility: Stefan Koinzer
city: Köln
country: Germany
facility: Poliklinik Leiter
city: Mainz
country: Germany
facility: Katrin Lorenz
city: München
country: Germany
facility: Klinikum der Universität München
city: Münster
country: Germany
facility: Ulrich Thelen
city: Prien a. Chiemsee
country: Germany
facility: Ines Lanzl
Study officials:
affiliation: University Hospital Munich
name: Elizabeth M Messmer, MD
role: PRINCIPAL_INVESTIGATOR
References: