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ADenoVirus Initiative Study in Epidemiology in Spain

NCT ID: NCT02254330

Last Updated: 2017-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

386 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Viral Conjunctivitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NicOx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose Manuel Benitez Del Castillo, MD

Role: PRINCIPAL_INVESTIGATOR

Ocumed Clinica Oftalmologica

Locations

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VISSUM

Alicante, , Spain

Site Status

Clinica Barraquer

Barcelona, , Spain

Site Status

Hospital Clinic

Barcelona, , Spain

Site Status

Instituto de Microcirugía Ocular

Barcelona, , Spain

Site Status

Instituto Clínico Quirúrgico de Oftalmología

Bilbao, , Spain

Site Status

Alcazar de San Juan

Ciudad Real, , Spain

Site Status

Hospital La Arruzafa

Córdoba, , Spain

Site Status

Ocumed Clinica Oftalmologica

Madrid, , Spain

Site Status

Fundacion Jimenez Diaz

Madrid, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital de Villalba

Madrid, , Spain

Site Status

Hospital Infanta Leonor-Vallecas

Madrid, , Spain

Site Status

Hospital La Paz

Madrid, , Spain

Site Status

Hospital Quiron

Madrid, , Spain

Site Status

Hospital Ramon Y Cajal

Madrid, , Spain

Site Status

Hospital Torrejon

Madrid, , Spain

Site Status

Instituto Oftalmologico Fernandez-Vega

Oviedo, , Spain

Site Status

Clinica Universitaria de Navarra

Pamplona, , Spain

Site Status

Hospital Universitario de Canarias

Santa Cruz de Tenerife, , Spain

Site Status

Hospital Clinico Santiago de Compostela

Santiago de Compostela, , Spain

Site Status

Hospital Clinico

Valencia, , Spain

Site Status

Hospital La Fe

Valencia, , Spain

Site Status

Hospital Clinico de Valladolid

Valladolid, , Spain

Site Status

Instituto Oftalmobiologia Aplicada

Valladolid, , Spain

Site Status

Hospital de Cruces, Baracaldo

Vizcaya, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ADVISE Spain

Identifier Type: -

Identifier Source: org_study_id

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