ADenoVirus Initiative Study in Epidemiology in France
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|ClinicalTrials.gov Identifier: NCT02054234|
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : February 10, 2015
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|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||357 participants|
|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 Start Date :||June 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
- Frequency of patients with adenovirus conjunctivitis [ Time Frame: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) ]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.
- Seasonality and geographic repartition observed. [ Time Frame: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) ]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).
- Clinical profiles of the patients [ Time Frame: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) ]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).
- Resource utilization during the treatment and evaluation of the costs [ Time Frame: On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s) ]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).
- Patient/parent absenteeism linked to this disease. [ Time Frame: On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s) ]Number of days out of work and/or out of school linked to this disease.
- Safety assessment [ Time Frame: On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s) ]Number of adverse incidents (AIs) and events that are of significant (SEs) reported to Nicox
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|Ages Eligible for Study:||1 Year and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054234
|Principal Investigator:||Eric Tuil||CHNO Des Quinze-Vingts|
|Other Study ID Numbers:||
|First Posted:||February 4, 2014 Key Record Dates|
|Last Update Posted:||February 10, 2015|
|Last Verified:||February 2015|
Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test
Eye Infections, Viral