Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT07298967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ORCHARDS-AIR Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 422}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2025-12-19', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of virus detection', 'timeFrame': 'Day 0, Day 7, Day 14', 'description': 'Participants will provide nasal swabs, which will be tested for a panel of viruses.'}, {'measure': 'Rate of air sampling detection among families with documented transmission', 'timeFrame': 'Day 7, Day 14', 'description': 'Study team will collect and test air sampler filter for viruses.'}, {'measure': 'Rate of air sampling detection among families without documented transmission', 'timeFrame': 'Day 7, Day 14', 'description': 'Study team will collect and test air sampler filter for viruses.'}, {'measure': 'Survey of symptoms - day 0', 'timeFrame': 'Day 0', 'description': "Qualitative survey of participants' symptoms and related activities."}, {'measure': 'Survey of symptoms - day 7', 'timeFrame': 'Day 7', 'description': "Qualitative survey of participants' symptoms and related activities."}, {'measure': 'Survey of symptoms - day 14', 'timeFrame': 'Day 14', 'description': "Qualitative survey of participants' symptoms and related activities."}, {'measure': 'Air sampler use survey', 'timeFrame': 'Day 7, Day 14', 'description': "Qualitative survey about participants' use of the air sampler."}], 'secondaryOutcomes': [{'measure': 'Number of absences', 'timeFrame': '14 days', 'description': 'Participants will self-report whether they were absent from school during the study period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Respiratory Infection', 'Influenza-like Illness']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to compare the effectiveness of air surveillance and to better understand the relationship between household transmission and viruses detected in the air.\n\nParticipants will provide nasal swabs and have an air sample surveillance device installed in their home.', 'detailedDescription': 'The purpose of ORCHARDS-AIR is to utilize air surveillance in participant homes in conjunction with individually collected nasal specimens to assess their concordance and evaluate the significance of airborne detection with household transmission of common respiratory pathogens such as influenza and SARS-CoV-2.\n\nThe researchers postulate that households with documented and probable respiratory pathogen transmission will have higher rates of in-home air surveillance detection. Students with more severe illnesses will be absent more often and spend more time at home, potentially leading to absenteeism being associated with greater air surveillance detections and intrahousehold transmission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria - Students:\n\n* Student attends, or is eligible to attend, a school within the Oregon School District (OSD)\n* Study has an illness characterized by at least 2 of 6 acute respiratory infection (ARI)/ILI symptoms (nasal discharge, nasal congestion, sneezing, sore throat, cough, fever) and student scores at least 2 points on the Jackson scale\n\nExclusion Criteria - Students:\n\n* Household member listed on Wisconsin Department of Corrections Sex Offender Registry\n* Illness onset more than 7 days before anticipated time of specimen collection\n* Anatomical defect for which nasal specimen collection is contraindicated\n* Student participated too recently (\\<7 days from day 14 during peak influenza / COVID-19 period and \\<30 days during other times, as determined by a medically-attended surveillance program)\n\nInclusion Criteria - Household member:\n\n* Live in the same household as eligible student participant\n* Any age and gender\n* Fluent in English\n* Able to provide appropriate consent or assent'}, 'identificationModule': {'nctId': 'NCT07298967', 'briefTitle': 'ORCHARDS-AIR Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'ORegon CHild Absenteeism Due to Respiratory Disease Study - Air Surveillance', 'orgStudyIdInfo': {'id': '2025-1617'}, 'secondaryIdInfos': [{'id': 'AS', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'UWMSN | SMPH | DFMCH Departmen', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 12/15/2025', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Students with ARI (acute respiratoy infection)', 'description': 'Students with ARI and their household members will provide nasal swabs', 'interventionNames': ['Diagnostic Test: Nasal swab', 'Device: Indoor air quality monitor']}], 'interventions': [{'name': 'Nasal swab', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will use a swab to collect nasal specimens', 'armGroupLabels': ['Students with ARI (acute respiratoy infection)']}, {'name': 'Indoor air quality monitor', 'type': 'DEVICE', 'description': 'InBio Apollo ambient air sampler to be run in the home for the duration of study participation. Material from the air, like aerosols, dust particles, and other environmental material, are collected on sampler filler material.', 'armGroupLabels': ['Students with ARI (acute respiratoy infection)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Shari Barlow', 'role': 'CONTACT', 'email': 'shari.barlow@fammed.wisc.edu', 'phone': '608-265-4348'}], 'overallOfficials': [{'name': 'Jonathan Temte, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}