ADenoVirus Initiative Study in Epidemiology in Italy

NCT03055065 | Completed

• 1 other identifier: ADVISE Italy
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 1

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.

Conditions

Viral Conjunctivitis

Keywords

Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test

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 (one visit)

Other Outcomes (9)

• data collection: Seasonality and geographic repartition observed.

  One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)

• Percentage of each eye signs and symptoms measured by questionnaire

  One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)

• Duration of the disease measured by questionnaire

  One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

Sponsors & Collaborators

• NicOx: lead

Study Sites (1)

Clinica oculistica / Ospedale san Paolo

Milan, 85 20142, Italy

Location

MeSH Terms

Conditions

Conjunctivitis, Viral

Condition Hierarchy (Ancestors)

Eye Infections, Viral; Eye Infections; Infections; Virus Diseases; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Study Officials

• Paolo Fogagnolo, MD

  Ospedale san Paolo Blocco

  PRINCIPAL INVESTIGATOR

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: February 16, 2017
• Study Start: November 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

IT (1)