Clinical trial NCT03055065: ADenoVirus Initiative Study in Epidemiology in Italy
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Viral Conjunctivitis
Keywords: Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test
Lead sponsor: NicOx
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 241
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

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.

Eligibility 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.

Primary outcomes:
measure: Frequency of patients with adenovirus conjunctivitis
timeFrame: During the visit to the ophthalmologist (one visit)
Secondary outcomes:
Other outcomes:
measure: data collection: Seasonality and geographic repartition observed.
timeFrame: One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
measure: Percentage of each eye signs and symptoms measured by questionnaire
timeFrame: One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
measure: Duration of the disease measured by questionnaire
timeFrame: One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
measure: Number of follow-up visits done measured by questionnaire
timeFrame: One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
measure: Diagnosis measured by questionnaire
timeFrame: One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
measure: Resource utilization during the treatment
timeFrame: 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
measure: Evaluation of the costs of resource utilization during the treatment
timeFrame: 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
measure: Patient/parent absenteeism linked to this disease measured by questionnaire
timeFrame: 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
measure: Safety assessment measured by data collection
timeFrame: 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
Locations:
city: Milano
country: Italy
facility: Clinica oculistica / Ospedale san Paolo
Study officials:
affiliation: Ospedale san Paolo Blocco
name: Paolo Fogagnolo, MD
role: PRINCIPAL_INVESTIGATOR
References: