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Completed

NCT Number: NCT03055065

ADenoVirus Initiative Study in Epidemiology in Italy

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.

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Key information

Conditions

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

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica oculistica / Ospedale san Paolo

Milan, 85 20142, Italy

About this study

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 Italy. The planned duration of the study is one year from the first patient visit to the last patient visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Frequency of patients with adenovirus conjunctivitis

    Time frame: During the visit to the ophthalmologist (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.

Other outcomes

  1. data collection: Seasonality and geographic repartition observed.

    Time frame: One day 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).

  2. Percentage of each eye signs and symptoms measured by questionnaire

    Time frame: One day 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 for both the patients with positive and negative AdenoPlus® tests

  3. Duration of the disease measured by questionnaire

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

    the mean duration of the disease for both the patients with positive and negative AdenoPlus® tests

  4. Number of follow-up visits done measured by questionnaire

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

    The number or follow-up visit done

  5. Diagnosis measured by questionnaire

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

    The correlation between the initial diagnosis (before AdenoPlus® test results) and the final diagnosis (post AdenoPlus® test results).

  6. Resource utilization during the treatment

    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) at latest one year following visit 1

    Estimation of resource utilized during course of treatment (use of drugs, number of visits done by the patient…), .

  7. Evaluation of the costs of resource utilization during the treatment

    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) at latest one year following visit 1

    associated costs of resources used during the treatment (use of drugs, number of visits done by the patient…), (which would be calculated by applying unit costs to resource use).

  8. Patient/parent absenteeism linked to this disease measured by questionnaire

    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) at latest one year following visit 1

    Number of days out of work and/or out of school linked to this disease.

  9. Safety assessment measured by data collection

    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) at latest one year following visit 1

    Number of adverse incidents (AIs) and events that are of significant (SEs) reported to Nicox

Sponsors and collaborators

Lead sponsor

NicOx

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 16, 2017
Registry last updated
Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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