ADenoVirus Initiative Study in Epidemiology in France

NCT ID: NCT02054234

Last Updated: 2015-02-10

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

357 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-12-31

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.

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 France. 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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Eric Tuil

Role: PRINCIPAL_INVESTIGATOR

CHNO Des Quinze-Vingts

Locations

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Hôpital Avicenne

Bobigny, , France

Site Status

Groupe hospitalier Pellegrin

Bordeaux, , France

Site Status

CHU BREST- Hôpital Morvan

Brest, , France

Site Status

Hôpital Kremlin-Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

CHRU de Lille

Lille, , France

Site Status

Hospices Civils de Lyon

Lyon, , France

Site Status

Hôpital de la Timone

Marseille, , France

Site Status

Hopital Nord

Marseille, , France

Site Status

GABISSON

Marseille, , France

Site Status

CH Nantes

Nantes, , France

Site Status

Centre hospitalier Saint Roch

Nice, , France

Site Status

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, , France

Site Status

Groupe Hospitalier La Pitié Salpêtrière-Charles Foix

Paris, , France

Site Status

Fondation Rothschild

Paris, , France

Site Status

Hôpital Tenon

Paris, , France

Site Status

Hôpital Hôtel Dieu

Paris, , France

Site Status

Hopital Pontchaillou

Rennes, , France

Site Status

Nouvel Hôpital Civil

Strasbourg, , France

Site Status

CHU Hôpital Bretonneau

Tours, , France

Site Status

Countries

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France

Other Identifiers

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ADVISE France

Identifier Type: -

Identifier Source: org_study_id

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