ADenoVirus Initiative Study in Epidemiology in Spain

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: NCT02254330
• Other study ID #: ADVISE Spain
• Status: Completed
• Phase: N/A
• First received: September 29, 2014
• Last updated: January 9, 2017
• Start date: July 2014
• Est. completion date: August 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 Spain. 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: 386
• Est. completion date: August 2015
• Est. primary completion date: August 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
Spain	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	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	Ocumed Clinica Oftalmologica	Madrid
Spain	Instituto Oftalmologico Fernandez-Vega	Oviedo
Spain	Clinica Universitaria de Navarra	Pamplona
Spain	Hospital Clinico Santiago de Compostela	Santiago de Compostela
Spain	Hospital Universitario de Canarias	Tenerife
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

Sponsors (1)

Lead Sponsor	Collaborator
NicOx

Country where clinical trial is conducted

Spain, 

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)