ADenoVirus Initiative Study in Epidemiology in France
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
357
1 country
19
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 Jun 2013
19 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
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 17, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 10, 2015
February 1, 2015
1.5 years
January 17, 2014
February 9, 2015
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 (19)
Hôpital Avicenne
Bobigny, France
Groupe hospitalier Pellegrin
Bordeaux, France
CHU BREST- Hôpital Morvan
Brest, 29609, France
Hôpital Kremlin-Bicêtre
Le Kremlin-Bicêtre, 94270, France
CHRU de Lille
Lille, France
Hospices Civils de Lyon
Lyon, France
Hôpital de la Timone
Marseille, 13385, France
Hopital Nord
Marseille, 13, France
GABISSON
Marseille, France
CH Nantes
Nantes, France
Centre hospitalier Saint Roch
Nice, 06000, France
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012, France
Groupe Hospitalier La Pitié Salpêtrière-Charles Foix
Paris, 75013, France
Fondation Rothschild
Paris, 75019, France
Hôpital Tenon
Paris, 75970, France
Hôpital Hôtel Dieu
Paris, France
Hopital Pontchaillou
Rennes, France
Nouvel Hôpital Civil
Strasbourg, 67000, France
CHU Hôpital Bretonneau
Tours, 37044, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Tuil
CHNO Des Quinze-Vingts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2014
First Posted
February 4, 2014
Study Start
June 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 10, 2015
Record last verified: 2015-02