Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-02-21 @ 10:02 AM
Study NCT ID:
NCT06424795
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular and Microbiome/Metagenome Correlates of Recurrent Wheeze in RSV Infected Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}, {'id': 'D012135', 'term': 'Respiratory Sounds'}], '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': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Two anterior nasal swabs and a nasal brush. Samples retained only if agreed to by Legally Authorized Representative on Parent Permission form'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-16', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medically confirmed recurrent wheeze', 'timeFrame': 'Follow-up for recurrent wheeze begins 6 weeks after the primary RSV infection and ends approximately one year later (including a subsequent RSv season).', 'description': 'Recurrent wheezing documented by a medical provider following primary RSV infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wheeze'], 'conditions': ['Respiratory Syncytial Virus Infection']}, 'referencesModule': {'references': [{'pmid': '19196675', 'type': 'BACKGROUND', 'citation': 'Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA, Auinger P, Griffin MR, Poehling KA, Erdman D, Grijalva CG, Zhu Y, Szilagyi P. The burden of respiratory syncytial virus infection in young children. N Engl J Med. 2009 Feb 5;360(6):588-98. doi: 10.1056/NEJMoa0804877.'}, {'pmid': '29733679', 'type': 'BACKGROUND', 'citation': 'Turi KN, Shankar J, Anderson LJ, Rajan D, Gaston K, Gebretsadik T, Das SR, Stone C, Larkin EK, Rosas-Salazar C, Brunwasser SM, Moore ML, Peebles RS Jr, Hartert TV. Infant Viral Respiratory Infection Nasal Immune-Response Patterns and Their Association with Subsequent Childhood Recurrent Wheeze. Am J Respir Crit Care Med. 2018 Oct 15;198(8):1064-1073. doi: 10.1164/rccm.201711-2348OC.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about further wheezing in infants with RSV infection.. The main question it aims to answer is:\n\nIf infant factors, the infant immune response in the nose and the bacteria that reside in the nose at the time of primary RSV infection can predict/classify infants with recurrent wheezing during the following year.\n\nA secondary aim is to identify infant immune response factors in the nose and patterns of bacteria in the nose during primary RSV infection that may help us understand why recurrent wheezing occurs.\n\nResearchers will compare infants with repeated episodes of wheezing to infants who do not have further wheezing.\n\nParticipants will be full term infants with their first RSV infection. We will collect information on the pregnancy and birth history as well as the signs and symptoms of RSV infection. Two nasal swabs and a nasal wash will be collected from the infants. Six weeks following the RSV infection we will begin contact with the families biweekly to determine if the infant has recurrent wheezing confirmed by a medical provider. Follow-up will continue for approximately 1 year, through a second winter season.', 'detailedDescription': "Respiratory syncytial virus (RSV) causes yearly epidemics of respiratory infection with a significant burden of disease in those at the extremes of age. Infants with RSV infection develop a range of illness from mild or in apparent upper respiratory infections to severe lower respiratory disease with wheezing and/or pneumonia. RSV infection is the most common cause of hospitalization in infants in the US.\n\nThe great majority (85%) of hospitalized infants are diagnosed with bronchiolitis and 78% are noted to have wheezing. RSV infection leads to even greater outpatient utilization of medical care including Emergency Department visits (39-69 per 1000 under 6 months and 45-68 per 1000 from 6-11 months) and visits to pediatricians (108-157/1000 under 6 months and 160-194 per 1000 from 6-11 months).\n\nFollowing primary RSV infection several epidemiological observations have identified an increased frequency of recurrent wheezing in 34 to 56% of infants.\n\nThe objectives of this study include:\n\nPrimary Objective: To test whether clinical factors, airway gene expression and microbiome/metagenome patterns in the nasal epithelium at the time of primary RSV infection can predict/classify infants with recurrent wheezing.\n\nSecondary Objective 1: To identify airway gene expression and microbiome/metagenome correlates of primary RSV infection that may inform pathogenic mechanisms associated with recurrent wheeze.\n\nHypotheses\n\nPrimary Hypothesis: Infants with recurrent wheeze following primary RSV infection will have a defined set of clinical, airway gene expression and/or airway microbiome/metagenome characteristics associated with a post bronchial wheezing phenotype.\n\nSecondary Hypothesis 1: Respiratory epithelial innate immune responses to primary RSV infection, and their interaction with microbiome composition and functional processes, will identify biological mechanisms contributing to post bronchial wheeze.\n\nThis is a single center, prospective, case-control observational study. Full term (\\>36 and 0/7 gestation) infants born after the prior RSV season of the prior year with primary RSV infection and no prior episodes of wheezing will be enrolled during their first RSV season from both outpatient and inpatient locations in Rochester New York. During the subsequent seasons of enrollment infants will meet the above eligibility requirements and also be tested and negative for acute infection with Severe Acute Respiratory Syndrome-Coronavirus-2.100 infants total with RSV infection will be enrolled with approximately 50 from the hospital and 50 from the Emergency Department (ED) or outpatient clinic in order to enroll infants with a range of severity, but with a focus on those presenting for medical care due to symptoms. Active surveillance for subsequent wheezing episodes will be conducted by phone/text/email follow-up every two weeks over the subsequent year, including a second full winter season for all subjects, beginning six weeks after the index illness. At the first report of subsequent wheezing a research clinic or home visit will be conducted to confirm the presence of wheezing by a trained staff member. Recurrent wheeze will be defined by two separate episodes of wheezing separated by at least 14 days with the first episode confirmed by study staff. In addition to this active surveillance, caregiver's will be asked to sign a medical records release for their child at the first visit that will cover the period of participation in the study. At the end of the study we will review each subject's medical records to determine if the child has had wheezing documented by a medical provider and not reported by the family. Once recurrent wheeze has been confirmed the subject will have reached an endpoint. At the end of the follow-up period the clinical and biological characteristics of participants with recurrent wheeze and those without recurrent wheeze will be compared."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Months', 'minimumAge': '3 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll previously healthy infants born after 36 0/7 weeks gestation during their first RSV infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent by Legally Authorized Representative\n2. Confirmed infection with RSV\n3. Gestational age at birth 36 and 0/7 weeks or greater\n4. No prior wheezing episodes\n5. Negative for acute infection with SARS-CoV-2\n6. First RSV season\n\nExclusion Criteria:\n\n1. Underlying disease (immune, cardiopulmonary, neuromuscular, renal) that would qualify for palivizumab\n2. Receiving immunosuppressive medications\n3. Live greater than 35 miles from University of Rochester Medical Center\n4. Parental inability to read or understand English'}, 'identificationModule': {'nctId': 'NCT06424795', 'briefTitle': 'Molecular and Microbiome/Metagenome Correlates of Recurrent Wheeze in RSV Infected Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Molecular and Microbiome/Metagenome Correlates of Recurrent Wheeze in RSV Infected Infants', 'orgStudyIdInfo': {'id': 'MISP 58711-062022-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infants with recurrent wheeze', 'description': 'Infants with recurrent wheeze in the year following primary RSV infection'}, {'label': 'Infants without recurrent wheeze', 'description': 'Infants without recurrent wheeze in the year following primary RSV infection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642-0001', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Mary T Caserta', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Mary Caserta', 'investigatorAffiliation': 'University of Rochester'}}}}