- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07298967
ORCHARDS-AIR Study
ORegon CHild Absenteeism Due to Respiratory Disease Study - Air Surveillance
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.
Participants will provide nasal swabs and have an air sample surveillance device installed in their home.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
The 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shari Barlow
- Phone Number: 608-265-4348
- Email: shari.barlow@fammed.wisc.edu
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- Recruiting
- University of Wisconsin-Madison
-
Contact:
- Shari Barlow
- Phone Number: 608-333-2653
- Email: shari.barlow@fammed.wisc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria - Students:
- Student attends, or is eligible to attend, a school within the Oregon School District (OSD)
- 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
Exclusion Criteria - Students:
- Household member listed on Wisconsin Department of Corrections Sex Offender Registry
- Illness onset more than 7 days before anticipated time of specimen collection
- Anatomical defect for which nasal specimen collection is contraindicated
- 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)
Inclusion Criteria - Household member:
- Live in the same household as eligible student participant
- Any age and gender
- Fluent in English
- Able to provide appropriate consent or assent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Students with ARI (acute respiratoy infection)
Students with ARI and their household members will provide nasal swabs
|
Participants will use a swab to collect nasal specimens
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of virus detection
Time Frame: Day 0, Day 7, Day 14
|
Participants will provide nasal swabs, which will be tested for a panel of viruses.
|
Day 0, Day 7, Day 14
|
|
Rate of air sampling detection among families with documented transmission
Time Frame: Day 7, Day 14
|
Study team will collect and test air sampler filter for viruses.
|
Day 7, Day 14
|
|
Rate of air sampling detection among families without documented transmission
Time Frame: Day 7, Day 14
|
Study team will collect and test air sampler filter for viruses.
|
Day 7, Day 14
|
|
Survey of symptoms - day 0
Time Frame: Day 0
|
Qualitative survey of participants' symptoms and related activities.
|
Day 0
|
|
Survey of symptoms - day 7
Time Frame: Day 7
|
Qualitative survey of participants' symptoms and related activities.
|
Day 7
|
|
Survey of symptoms - day 14
Time Frame: Day 14
|
Qualitative survey of participants' symptoms and related activities.
|
Day 14
|
|
Air sampler use survey
Time Frame: Day 7, Day 14
|
Qualitative survey about participants' use of the air sampler.
|
Day 7, Day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of absences
Time Frame: 14 days
|
Participants will self-report whether they were absent from school during the study period.
|
14 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathan Temte, MD, PhD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-1617
- AS (Other Identifier: UW Madison)
- UWMSN | SMPH | DFMCH Departmen (Other Identifier: UW Madison)
- Protocol Version 12/15/2025 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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