Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT02847156
Status:
COMPLETED
Last Update Posted:
2016-07-28
First Post:
2016-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Respiratory Viral Infections in Infants With Cystic Fibrosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-25', 'studyFirstSubmitDate': '2016-07-25', 'studyFirstSubmitQcDate': '2016-07-25', 'lastUpdatePostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Respiratory Viral Infection', 'timeFrame': 'up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Identification of respiratory viruses in throat-swabs', 'timeFrame': 'up to 12 months', 'description': 'A panel of 10 viruses will be tested using polymerase chain reaction (PCR) and RT-PCR technology.'}, {'measure': 'Number of antibiotics treatments (oral or IV)', 'timeFrame': 'up to 12 months'}, {'measure': 'Number of bronchodilator administrations', 'timeFrame': 'up to 12 months'}, {'measure': 'Number of corticosteroids administrations', 'timeFrame': 'up to 12 months'}, {'measure': 'Number of hospitalization or hospital admission due to upper or lower RVI', 'timeFrame': 'up to 12 months'}, {'measure': 'Identification of bacterial flora in throat-swabs', 'timeFrame': 'up to 12 months'}]}, 'conditionsModule': {'keywords': ['cystic fibrosis', 'viruses', 'respiratory viral infection', 'children'], 'conditions': ['Cystic Fibrosis', 'Respiratory Viral Infection']}, 'descriptionModule': {'briefSummary': 'Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF children are rare and the impact of most frequent viruses such as human rhinoviruses is usually not correctly evaluated.\n\nThe aim of this study is to assess the frequency of lower and upper RVI during a 1 year follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and therapeutic level.\n\nOur hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the short term and without any particular link with a specific virus as previously described.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- infant \\<24 months with cystic fibrosis\n\nExclusion Criteria:\n\n\\- patient \\>24 months'}, 'identificationModule': {'nctId': 'NCT02847156', 'acronym': 'PREVIMUC', 'briefTitle': 'Impact of Respiratory Viral Infections in Infants With Cystic Fibrosis.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Clinical and Microbiological Impact of Respiratory Viral Infections in the Short and Medium Term in Infants (<24 Months) With Cystic Fibrosis.', 'orgStudyIdInfo': {'id': '69HCL14_0276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'cystic fibrosis infants', 'description': '1 year follow-up in CF infants', 'interventionNames': ['Other: Physical assessment']}], 'interventions': [{'name': 'Physical assessment', 'type': 'OTHER', 'description': '1 year follow-up in CF infants with clinical, microbiological and therapeutic assessments', 'armGroupLabels': ['cystic fibrosis infants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'Stéphanie VRIELYNCK, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon, 69677 Bron Cedex, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}