The Rhinovirus Hospitalization and Investigation of Nasal-airway Omics (RHINO) Study

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07342582
Status
Not Yet Recruiting

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Conditions

  • Rhinovirus

Eligibility Criteria

Sex
ALL
Age
N/A - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Nasal Swab Healthy Surveillance — DIAGNOSTIC_TEST
    Families will be asked to collect nasal swabs from their children during specified surveillance months (February, April, September, and December). Caregivers will be instructed to only collect surveillance samples during these months if and when children have been free of respiratory symptoms for at least two weeks prior to sampling. Caregiver surveys are part of quarterly surveillance.
  • Nasal Swab Sick Samples — DIAGNOSTIC_TEST
    Caregivers will be instructed to watch for respiratory symptoms and collect nasal swabs 24-48 hours after symptom onset. Caregiver surveys are part of sick sample collection
  • Nasal Swab Hospitalized Cohort — DIAGNOSTIC_TEST
    2 nasal swabs collected upon consent, one anterior and one mid-turbinate
  • Sick Follow-up Survey — OTHER
    Caregivers are surveyed 7-13 days after sick sample collection
  • Older Cohort Control Group — OTHER
    Participants will be enrolled as needed based on enrollment of hospitalized patients

Study Details

The goal of this study is to determine the burden of Rhinoviruses (RVs) as a cause of acute, severe, respiratory illnesses leading to hospitalization. A community cohort of 120 children between 12 and 36 months of age will be enrolled in the first year of the study and followed (when well and sick) for 36 months to identify the circulating RVs and provide samples to establish a host nasal transcriptome differentiating clinical from subclinical RV infections. A hospitalized cohort of 450 infants and children will be enrolled during years 1 through 3 of the study and followed for the duration of their hospitalization to investigate the findings of the community cohort. An additional 100 healthy children aged 5-17 years will be enrolled for age-match comparison with the older hospitalized cohort.

Key Dates

Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
May 31, 2030
Completion
May 31, 2030

Study Design

Enrollment
670 participants (estimated)

Arms

  • Arm: Younger Community Cohort (12-36 months of age)
    Quarterly Surveillance Nasal Swabs and Nasal Swabs targeted around respiratory symptoms for up to 36 months of age, participants will provide one anterior and one mid-turbinate nasal swab sample
  • Arm: Hospitalized Cohort of Infants and Children
    Generally healthy infants and children hospitalized for respiratory illness will provide one anterior and one mid-turbinate nasal swab sample
  • Arm: Older Community Cohort (5 to 17 years of age)
    Age-matched controls for older children in the Hospitalized Group, will be called upon as needed based on enrollment of hospitalized patients

Primary Outcome Measure

Aim 1: Summary of Rhinovirus Types Identified in Community Cohort [ Time Frame: data collected up to 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53792-

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By research site
University of Wisconsin· Madison, WI

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