Clinical trial NCT02254330: ADenoVirus Initiative Study in Epidemiology in Spain
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: 2014-10-01
Enrollment: 386
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 Spain. 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: Alicante
country: Spain
facility: VISSUM
city: Barcelona
country: Spain
facility: Clinica Barraquer
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Instituto de Microcirugía Ocular
city: Bilbao
country: Spain
facility: Instituto Clínico Quirúrgico de Oftalmología
city: Ciudad Real
country: Spain
facility: Alcazar de San Juan
city: Córdoba
country: Spain
facility: Hospital La Arruzafa
city: Madrid
country: Spain
facility: Ocumed Clinica Oftalmologica
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital de Villalba
city: Madrid
country: Spain
facility: Hospital Infanta Leonor-Vallecas
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Quiron
city: Madrid
country: Spain
facility: Hospital Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Torrejon
city: Oviedo
country: Spain
facility: Instituto Oftalmologico Fernandez-Vega
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Santiago de Compostela
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Valencia
country: Spain
facility: Hospital Clinico
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valladolid
country: Spain
facility: Hospital Clinico de Valladolid
city: Valladolid
country: Spain
facility: Instituto Oftalmobiologia Aplicada
city: Vizcaya
country: Spain
facility: Hospital de Cruces, Baracaldo
Study officials:
affiliation: Ocumed Clinica Oftalmologica
name: Jose Manuel Benitez Del Castillo, MD
role: PRINCIPAL_INVESTIGATOR
References: