ADenoVirus Initiative Study in Epidemiology in Spain
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
1 other identifier
observational
386
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 29, 2014
CompletedFirst Posted
Study publicly available on registry
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJanuary 10, 2017
January 1, 2017
1.1 years
September 29, 2014
January 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Seasonality and geographic repartition observed.
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
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
On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s)
- +2 more other outcomes
Eligibility Criteria
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
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NicOxlead
Study Sites (25)
VISSUM
Alicante, Spain
Clinica Barraquer
Barcelona, Spain
Hospital Clinic
Barcelona, Spain
Instituto de Microcirugía Ocular
Barcelona, Spain
Instituto Clínico Quirúrgico de Oftalmología
Bilbao, Spain
Alcazar de San Juan
Ciudad Real, Spain
Hospital La Arruzafa
Córdoba, Spain
Ocumed Clinica Oftalmologica
Madrid, 28023, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital de Villalba
Madrid, Spain
Hospital Infanta Leonor-Vallecas
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital Quiron
Madrid, Spain
Hospital Ramon Y Cajal
Madrid, Spain
Hospital Torrejon
Madrid, Spain
Instituto Oftalmologico Fernandez-Vega
Oviedo, Spain
Clinica Universitaria de Navarra
Pamplona, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Hospital Clinico Santiago de Compostela
Santiago de Compostela, Spain
Hospital Clinico
Valencia, Spain
Hospital La Fe
Valencia, Spain
Hospital Clinico de Valladolid
Valladolid, Spain
Instituto Oftalmobiologia Aplicada
Valladolid, Spain
Hospital de Cruces, Baracaldo
Vizcaya, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Manuel Benitez Del Castillo, MD
Ocumed Clinica Oftalmologica
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2014
First Posted
October 1, 2014
Study Start
July 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
January 10, 2017
Record last verified: 2017-01