ADenoVirus Initiative Study in Epidemiology in Italy

Viral Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055065
• Other study ID #: ADVISE Italy
• Status: Completed
• Phase: N/A
• First received: September 29, 2014
• Last updated: February 13, 2017
• Start date: November 2014
• Est. completion date: October 2015

Study information

• Verified date: February 2017
• Source: NicOx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Viral
• Viral Conjunctivitis

Locations

Country	Name	City	State
Italy	Clinica oculistica / Ospedale san Paolo	Milano

Sponsors (1)

Lead Sponsor	Collaborator
NicOx

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	data collection: Seasonality and geographic repartition observed.	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).	One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
Other	Percentage of each eye signs and symptoms measured by questionnaire	The percentage of each eye signs and symptoms for both the patients with positive and negative AdenoPlus® tests	One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
Other	Duration of the disease measured by questionnaire	the mean duration of the disease for both the patients with positive and negative AdenoPlus® tests	One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
Other	Number of follow-up visits done measured by questionnaire	The number or follow-up visit done	One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
Other	Diagnosis measured by questionnaire	The correlation between the initial diagnosis (before AdenoPlus® test results) and the final diagnosis (post AdenoPlus® test results).	One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
Other	Resource utilization during the treatment	Estimation of resource utilized during course of treatment (use of drugs, number of visits done by the patient…), .	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
Other	Evaluation of the costs of resource utilization during the treatment	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).	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
Other	Patient/parent absenteeism linked to this disease measured by questionnaire	Number of days out of work and/or out of school linked to this disease.	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
Other	Safety assessment measured by data collection	Number of adverse incidents (AIs) and events that are of significant (SEs) reported to Nicox	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
Primary	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)