Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT00815802
Status:
COMPLETED
Last Update Posted:
2008-12-30
First Post:
2008-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Human Cytomegalovirus in the Saliva
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 655}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'lastUpdateSubmitDate': '2008-12-29', 'studyFirstSubmitDate': '2008-12-29', 'studyFirstSubmitQcDate': '2008-12-29', 'lastUpdatePostDateStruct': {'date': '2008-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'One week trial of saliva sampling for cytomegalovirus detection in day-care centers.'}], 'secondaryOutcomes': [{'measure': 'Percentage of chidrens with CMV excretion among those coming at the Emergency department of Limoges teacher Hospital (CHU). Validation of the process from samples collection to interpretation of results'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Children in day care centers', 'cytomegalovirus excretion'], 'conditions': ['Cytomegalovirus']}, 'descriptionModule': {'briefSummary': 'Direct DNA amplification, viral isolation and specific antibody measurement in saliva\n\n1. From children in day care centers (samples collection will take place during a single week)\n2. From children coming at the emergency department of our hospital during a three months period.\n\nSample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.', 'detailedDescription': 'Salivary collection kit. Collection of salivary at the internal face of the mooth. 3 swab for DNA research, 1 for antibodies research and 1 for virus isolation by cell growth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'child aged from 3 month to 6 years in day care centers or in emergency department.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parents consent\n* child aged from 3months to 6 years\n* child in day care centers or emergency department\n\nExclusion Criteria:\n\n* Refuse of participation'}, 'identificationModule': {'nctId': 'NCT00815802', 'acronym': 'FcrèchMV', 'briefTitle': 'Detection of Human Cytomegalovirus in the Saliva', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Detection of Human Cytomegalovirus in the Saliva of 3 Month to 6 Year-Old Children in Day Care Centers : a Pilot Study.', 'orgStudyIdInfo': {'id': 'I07017'}}, 'contactsLocationsModule': {'locations': [{'zip': '87', 'city': 'Limoges', 'country': 'France', 'facility': 'Bactériologie-Virologie', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}], 'overallOfficials': [{'name': 'Sophie ALAIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Limoges'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}}}}