Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-27 @ 2:54 AM
Study NCT ID:
NCT01159795
Status:
TERMINATED
Last Update Posted:
2016-11-11
First Post:
2010-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying Innate Immune Responses in Infants With Bronchiolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001988', 'term': 'Bronchiolitis'}], 'ancestors': [{'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood plasma - cytokines Blood EDTA - DNA Blood PAXgene tube - RNA Nasal lining fluid - cytokines Nasal mucosal lining - RNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'whyStopped': 'Awaiting further funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-10', 'studyFirstSubmitDate': '2010-07-06', 'studyFirstSubmitQcDate': '2010-07-08', 'lastUpdatePostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nasal and blood interferon alpha, beta, lambda levels(protein level and gene expression)', 'timeFrame': 'At presentation (average = day 4 of symptoms)', 'description': 'Interferon alpha, beta and lambda protein levels will be measured by ELISA and gene expression by quantitative real-time PCR, on paired nasal and blood samples.'}], 'secondaryOutcomes': [{'measure': 'RSV viral load', 'timeFrame': 'At presentation (average = day 4 of symptoms)', 'description': 'RSV viral load will be measured by quantitataive real-time PCR on nasal epithelium samples.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Respiratory Syncytial Virus', 'Infant', 'Interferon'], 'conditions': ['Bronchiolitis']}, 'descriptionModule': {'briefSummary': 'This study aims to establish whether impaired innate immune responses are associated with severity of Respiratory syncytial virus (RSV) infection.', 'detailedDescription': 'Respiratory syncytial virus (RSV) causes a spectrum of illness in healthy infants, ranging from asymptomatic infection to life threatening bronchiolitis with respiratory failure. The reasons for the differences in clinical presentation remain unknown. Interferons are natural antiviral factors and components of the innate immune response, which play a role in limiting viral replication.\n\nWe postulate that differences in clinical severity of RSV infection may be due to innate immune differences in the production of type I and III interferons (innate interferons). To test this hypothesis, we will recruit infants with mild, moderate and severe RSV bronchiolitis and compare production of innate interferons in blood and respiratory samples, using quantitative and functional analysis. We will determine whether interferon responses differ across a spectrum of clinical severity, and will relate them to viral load.\n\nTo establish whether defects in interferon production persist in those infants with severe infection, we will retest them following recovery and measure interferon responses after challenge with live RSV. Demonstrating a persisting defect may suggest a genetically determined defect requiring further investigation. Identification of the mechanisms of severe disease in patients without known risk-factors could lead to targeted therapy to prevent or treat severe disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '6 Weeks', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Infants presenting with bronchiolitis presenting to St Mary's Hospital, London", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bronchiolitis\n* Infant\n\nExclusion Criteria:\n\n* Age over 1 year\n* Underlying chronic lung disease, prematurity, congenital heart disease'}, 'identificationModule': {'nctId': 'NCT01159795', 'briefTitle': 'Studying Innate Immune Responses in Infants With Bronchiolitis', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Investigating Type I and Type III Interferon Responses in Infants With Respiratory Syncytial Virus', 'orgStudyIdInfo': {'id': '10/H0707/24'}}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': "St Mary's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Michael Levin, FMed Sci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Paediatrics, Imperial College London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}