<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02254330</url>
  </required_header>
  <id_info>
    <org_study_id>ADVISE Spain</org_study_id>
    <nct_id>NCT02254330</nct_id>
  </id_info>
  <brief_title>ADenoVirus Initiative Study in Epidemiology in Spain</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NicOx</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NicOx</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study is to assess the characteristics and frequency of adenovirus&#xD;
      conjunctivitis in a population of male and female patients from one year of age who present&#xD;
      signs and symptoms of acute conjunctivitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epidemiological, prospective, open, multicentric trial in patients suffering from acute&#xD;
      conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the&#xD;
      time of their visit to the ophthalmologist office, at the emergency room or during&#xD;
      hospitalization. This epidemiological study will include approximately 500 patients in Spain.&#xD;
      The planned duration of the study is one year from the first patient visit to the last&#xD;
      patient visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of patients with adenovirus conjunctivitis</measure>
    <time_frame>During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Seasonality and geographic repartition observed.</measure>
    <time_frame>During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)</time_frame>
    <description>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).</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical profiles of the patients</measure>
    <time_frame>During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)</time_frame>
    <description>The percentage of each eye signs and symptoms, the mean duration of the disease for both the patients with positive and negative AdenoPlus® tests, the number or follow-up visit done and the correlation between the initial diagnosis (before AdenoPlus® test results) and the final diagnosis (post AdenoPlus® test results).</description>
  </other_outcome>
  <other_outcome>
    <measure>Resource utilization during the treatment and evaluation of the costs</measure>
    <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)</time_frame>
    <description>Estimation of resource utilized during course of treatment (use of drugs, number of visits done by the patient…), and associated costs (which would be calculated by applying unit costs to resource use).</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient/parent absenteeism linked to this disease.</measure>
    <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)</time_frame>
    <description>Number of days out of work and/or out of school linked to this disease.</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety assessment</measure>
    <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)</time_frame>
    <description>Number of adverse incidents (AIs) and events that are of significant (SEs) reported to Nicox</description>
  </other_outcome>
  <enrollment type="Actual">386</enrollment>
  <condition>Viral Conjunctivitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Any female and male patients from one year of age with signs and symptoms of acute&#xD;
        conjunctivitis either seen during ophthalmology consultations or who are in the emergency&#xD;
        room or hospitalized, can be enrolled in the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female patients of at least one year of age presenting acute (for less than 7&#xD;
             days) conjunctivitis signs and symptoms.&#xD;
&#xD;
          -  Patient or / and legal representative (if patient below 18 years of age) must be able&#xD;
             to provide oral consent for the collection and treatment of the questionnaire data.&#xD;
&#xD;
          -  No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling&#xD;
             fleece components).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use or having received (within the last 7 days) local antiviral therapies such&#xD;
             as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as&#xD;
             cyclosporine which may interfere with the test result.&#xD;
&#xD;
          -  Previous enrolment in the present study.&#xD;
&#xD;
          -  Any direct involvement with the study conduct at site or any family link with study&#xD;
             site staff.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose Manuel Benitez Del Castillo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ocumed Clinica Oftalmologica</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VISSUM</name>
      <address>
        <city>Alicante</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Barraquer</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Microcirugía Ocular</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Clínico Quirúrgico de Oftalmología</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcazar de San Juan</name>
      <address>
        <city>Ciudad Real</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Arruzafa</name>
      <address>
        <city>Córdoba</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocumed Clinica Oftalmologica</name>
      <address>
        <city>Madrid</city>
        <zip>28023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Villalba</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infanta Leonor-Vallecas</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quiron</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramon Y Cajal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Torrejon</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Oftalmologico Fernandez-Vega</name>
      <address>
        <city>Oviedo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universitaria de Navarra</name>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Santiago de Compostela</name>
      <address>
        <city>Santiago de Compostela</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Canarias</name>
      <address>
        <city>Tenerife</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Fe</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Oftalmobiologia Aplicada</name>
      <address>
        <city>Valladolid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Cruces, Baracaldo</name>
      <address>
        <city>Vizcaya</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Conjunctivitis, Viral</mesh_term>
    <mesh_term>Conjunctivitis</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>March 7, 2017</submitted>
    <returned>April 18, 2017</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02254330
org study id: ADVISE Spain
nct id: NCT02254330
lead sponsor: 
has dmc: No
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.
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 Spain.
      The planned duration of the study is one year from the first patient visit to the last
      patient visit.
observational model: Cohort
time perspective: Cross-Sectional
measure: Frequency of patients with adenovirus conjunctivitis
time frame: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
description: 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.
measure: Seasonality and geographic repartition observed.
time frame: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
description: 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).
measure: Clinical profiles of the patients
time frame: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
description: The percentage of each eye signs and symptoms, the mean duration of the disease for both the patients with positive and negative AdenoPlus® tests, the number or follow-up visit done and the correlation between the initial diagnosis (before AdenoPlus® test results) and the final diagnosis (post AdenoPlus® test results).
measure: Resource utilization during the treatment and evaluation of the costs
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)
description: Estimation of resource utilized during course of treatment (use of drugs, number of visits done by the patient…), and associated costs (which would be calculated by applying unit costs to resource use).
measure: Patient/parent absenteeism linked to this disease.
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)
description: Number of days out of work and/or out of school linked to this disease.
measure: Safety assessment
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)
description: Number of adverse incidents (AIs) and events that are of significant (SEs) reported to Nicox
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
last name: Jose Manuel Benitez Del Castillo, MD
role: Principal Investigator
affiliation: Ocumed Clinica Oftalmologica
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country: Spain
responsible party type: Sponsor
mesh term: Conjunctivitis, Viral
mesh term: Conjunctivitis
submitted: March 7, 2017
returned: April 18, 2017