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ADenoVirus Initiative Study in Epidemiology in Italy

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ClinicalTrials.gov Identifier: NCT03055065
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
NicOx

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.

Condition or disease
Viral Conjunctivitis

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 241 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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 : November 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye




Primary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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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
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
Criteria

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.

Information from the National Library of Medicine

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): NCT03055065


Locations
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Italy
Clinica oculistica / Ospedale san Paolo
Milano, Italy, 85 20142
Sponsors and Collaborators
NicOx
Investigators
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Principal Investigator: Paolo Fogagnolo, MD Ospedale san Paolo Blocco
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Responsible Party: NicOx
ClinicalTrials.gov Identifier: NCT03055065    
Other Study ID Numbers: ADVISE Italy
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Keywords provided by NicOx:
Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test
Additional relevant MeSH terms:
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Conjunctivitis, Viral
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Eye Infections, Viral
Virus Diseases
Eye Infections