Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-02-26 @ 11:44 PM
Study NCT ID:
NCT00593918
Status:
COMPLETED
Last Update Posted:
2015-10-20
First Post:
2008-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Innate Immunity and Respiratory Syncytial Virus (RSV) Infection in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'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'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tguilbert@wisc.edu', 'phone': '608-263-9608', 'title': 'Theresa Guilbert, MD', 'organization': 'University of Wisconsin-Madison'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Subject withdraw before blood draw on second visit and small numbers recruited lead to small numbers of subjects analyzed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Toll-like Receptor 4 GG Genotype', 'description': 'Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Toll-like Receptor 4 AG/AA Genotypes', 'description': 'Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection', 'otherNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Nasal Interferon (IFN)-a2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toll-like Receptor 4 GG Genotype', 'description': 'Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection'}, {'id': 'OG001', 'title': 'Toll-like Receptor 4 AG/AA Genotypes', 'description': 'Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '3', 'groupId': 'OG000'}, {'value': '26', 'spread': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'A mixed random effects model was used both unadjusted and adjustment for relevant co-variates obtained from the literature.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1-5 days during acute illness (not after day 5 of illness)', 'description': 'Interferon a2 was measured from nasal lavage samples by Luminex multiplex assay.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was per protocol based on the number of children enrolled by genotype and completed nasal washes at first visit.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detected Nasal Interferon (IL)-2 Cytokine Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toll-like Receptor 4 GG Genotype', 'description': 'Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection'}, {'id': 'OG001', 'title': 'Toll-like Receptor 4 AG/AA Genotypes', 'description': 'Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Analysis was per protocol based on the number of children enrolled by genotype and completed nasal washes at first visit.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'A mixed random effects model was used both unadjusted and adjustment for relevant co-variates obtained from the literature.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1-5 days during acute illness (not after day 5 of illness)', 'description': 'IL-2 measured from nasal lavage samples by Luminex multiplex assay', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Toll-like Receptor 4 GG Genotype', 'description': 'Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection'}, {'id': 'FG001', 'title': 'Toll-like Receptor 4 AG/AA Genotypes', 'description': 'Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number of children with Toll-like Receptor 4 (TLR4) -2026/GG Genotype', 'groupId': 'FG000', 'numSubjects': '17'}, {'comment': 'Number of children with Toll-like Receptor 4 (TLR4) -2026/AG and AA genotypes', 'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Some children did not come in for the blood draw at visit 2', 'groupId': 'FG000', 'numSubjects': '12'}, {'comment': 'Some children did not come in for the blood draw at visit 2', 'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '24'}]}]}], 'recruitmentDetails': 'Study details planned during the first 4 months of the study. Recruitment period began during the RSV seasons from November to May each year from 2003-2008 in medical clinics.', 'preAssignmentDetails': 'Patients were enrolled if they met the enrollment criteria'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Toll-like Receptor 4 GG Genotype', 'description': 'Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection'}, {'id': 'BG001', 'title': 'Toll-like Receptor 4 AG/AA Genotypes', 'description': 'Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'spread': '0.56', 'groupId': 'BG000'}, {'value': '0.82', 'spread': '0.54', 'groupId': 'BG001'}, {'value': '0.82', 'spread': '0.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Nasal samples Supernatant from Peripheral mononuclear cell stimulation cultures DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-30', 'studyFirstSubmitDate': '2008-01-03', 'resultsFirstSubmitDate': '2009-06-19', 'studyFirstSubmitQcDate': '2008-01-14', 'lastUpdatePostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-04-13', 'studyFirstPostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nasal Interferon (IFN)-a2', 'timeFrame': '1-5 days during acute illness (not after day 5 of illness)', 'description': 'Interferon a2 was measured from nasal lavage samples by Luminex multiplex assay.'}, {'measure': 'Percentage of Participants With Detected Nasal Interferon (IL)-2 Cytokine Expression', 'timeFrame': '1-5 days during acute illness (not after day 5 of illness)', 'description': 'IL-2 measured from nasal lavage samples by Luminex multiplex assay'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['RSV, asthma, innate immunity, gene, cytokines'], 'conditions': ['Respiratory Syncytial Virus Infection']}, 'descriptionModule': {'briefSummary': 'In this project we will study the capacity for single nucleotide polymorphisms (SNP) in TLR4 gene to induce varying levels of inflammatory chemokine and cytokine production.', 'detailedDescription': 'Infection with RSV is the most common cause of respiratory tract illnesses (LRIs) in the first 3 years of life. There are significant social and health care costs associated with RSV-LRIs. More than 3% of US children are hospitalized each year due to RSV and 500 die annually. Several longitudinal studies have also suggested that children who have RSV-LRIs are at substantially increased risk of developing asthma in the first 3 years after infection and bronchial hyperresponsiveness (BHR) many years after the primary infection. Mechanisms involved in RSV disease are not well understood. Recent reports suggest that RSV may initiate the innate immune response through the pattern recognition receptor, Toll like receptor-4 (TLR4). In this project we will study the capacity for single nucleotide polymorphisms (SNP) in TLR4 gene to induce varying levels of inflammatory chemokine and cytokine production. It has been suggested that such a mechanism may result in altered immune responses to RSV infection and different clinical outcomes. This research has direct application to improving our understanding of bronchiolitis in early childhood, particularly those factors that influence severity of the disease, and may have implications for possible therapy of patients with bronchiolitis in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children who present with viral upper respiratory infections or bronchiolitis to their primary care physician. Upon consent, children willl have cheek samples for genotyping and nasal secretion samples to determine RSV infection.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Parental or sibling history of asthma.\n2. Child must be less than 24 months of age.\n3. Presence of viral upper or lower respiratory tract symptoms.\n\nExclusion Criteria:\n\n1. History of recurrent wheezing requiring systemic corticosteroids.\n2. Prior history of lung disease.\n3. Birth \\< 36 weeks gestation.\n4. Immunodeficiency\n5. Treatment with ribavirin, systemic or inhaled corticosteroids during the RSV infection.\n6. Congenital heart disease.\n7. No history of parental or sibling asthma.\n8. Less than 48 hour or more than 5 day duration of viral URI symptoms since the peak symptoms from RSV would be expected to occur from 2-5 days into course of infection.'}, 'identificationModule': {'nctId': 'NCT00593918', 'acronym': 'IIRI', 'briefTitle': 'Innate Immunity and Respiratory Syncytial Virus (RSV) Infection in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Innate Immunity and RSV Infection in Children', 'orgStudyIdInfo': {'id': '7K08HL071742-05', 'link': 'https://reporter.nih.gov/quickSearch/7K08HL071742-05', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Toll-like Receptor 4 -2026/GG Genotype', 'description': 'Toll-like Receptor 4 (TLR4) -2026/GG Genotype of interest hypothesized to be associated with less inflammation during Respiratory Syncytial virus (RSV) infection'}, {'label': 'Toll-like Receptor 4 -2026/AG and AA Genotypes', 'description': 'Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during respiratory syncytial virus (RSV) infection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792-9988', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Theresa W. Guilbert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}