Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-01-08 @ 1:39 PM
Study NCT ID:
NCT02054234
Status:
COMPLETED
Last Update Posted:
2015-02-10
First Post:
2014-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADenoVirus Initiative Study in Epidemiology in France
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2017-01-10', 'unreleaseDateUnknown': True}, {'resetDate': '2017-04-18', 'releaseDate': '2017-03-07'}], 'estimatedResultsFirstSubmitDate': '2017-01-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003236', 'term': 'Conjunctivitis, Viral'}], 'ancestors': [{'id': 'D015828', 'term': 'Eye Infections, Viral'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 357}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-09', 'studyFirstSubmitDate': '2014-01-17', 'studyFirstSubmitQcDate': '2014-02-03', 'lastUpdatePostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Seasonality and geographic repartition observed.', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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.', 'timeFrame': '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', 'timeFrame': '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'}], 'primaryOutcomes': [{'measure': 'Frequency of patients with adenovirus conjunctivitis', 'timeFrame': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test'], 'conditions': ['Viral Conjunctivitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 France. The planned duration of the study is one year from the first patient visit to the last patient visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms.\n* 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.\n* No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components).\n\nExclusion Criteria:\n\n* 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.\n* Previous enrolment in the present study.\n* Any direct involvement with the study conduct at site or any family link with study site staff.'}, 'identificationModule': {'nctId': 'NCT02054234', 'briefTitle': 'ADenoVirus Initiative Study in Epidemiology in France', 'organization': {'class': 'INDUSTRY', 'fullName': 'NicOx'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ADVISE France'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bobigny', 'country': 'France', 'facility': 'Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Groupe hospitalier Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHU BREST- Hôpital Morvan', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Hôpital Kremlin-Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'GABISSON', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CH Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Centre hospitalier Saint Roch', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': "Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier La Pitié Salpêtrière-Charles Foix', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Fondation Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Hôtel Dieu', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Hopital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Nouvel Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU Hôpital Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Eric Tuil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHNO Des Quinze-Vingts'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NicOx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-01-10', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2017-03-07', 'type': 'RELEASE'}, {'date': '2017-04-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'NicOx'}}}}