- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03055065
ADenoVirus Initiative Study in Epidemiology in Italy
February 13, 2017 updated by: NicOx
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
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
241
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Milano, Italy, 85 20142
- Clinica oculistica / Ospedale san Paolo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of patients with adenovirus conjunctivitis
Time Frame: During the visit to the ophthalmologist (one visit)
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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.
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During the visit to the ophthalmologist (one visit)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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).
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One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
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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)
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The percentage of each eye signs and symptoms for both the patients with positive and negative AdenoPlus® tests
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One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
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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)
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the mean duration of the disease for both the patients with positive and negative AdenoPlus® tests
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One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
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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)
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The number or follow-up visit done
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One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
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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)
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The correlation between the initial diagnosis (before AdenoPlus® test results) and the final diagnosis (post AdenoPlus® test results).
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One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
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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
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Estimation of resource utilized during course of treatment (use of drugs, number of visits done by the patient…), .
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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
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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
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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).
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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
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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
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Number of days out of work and/or out of school linked to this disease.
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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
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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
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Number of adverse incidents (AIs) and events that are of significant (SEs) reported to Nicox
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paolo Fogagnolo, MD, Ospedale san Paolo Blocco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
September 29, 2014
First Submitted That Met QC Criteria
February 13, 2017
First Posted (Actual)
February 16, 2017
Study Record Updates
Last Update Posted (Actual)
February 16, 2017
Last Update Submitted That Met QC Criteria
February 13, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADVISE Italy
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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