Recruiting

Rhinoviruses Burden

Sponsor:

University of Wisconsin, Madison

Code:

NCT07342582

Conditions

Rhinovirus

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Accepted

Interventions

Nasal Swab Healthy Surveillance

Nasal Swab Sick Samples

Nasal Swab Hospitalized Cohort

Sick Follow-up Survey

Older Cohort Control Group

Study Details

Brief summary:

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 5-17.5 years will be enrolled for age-match comparison with the older hospitalized cohort.

Conditions

Rhinovirus

Study ID

NCT07342582

Start date

Aug 4, 2026

Status verified date

Jul, 2026

Completion date

May, 2030

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Accepted

Inclusion Criteria (Aim 1 and Aim 2b Community Groups):

  • Parent/legal guardian is willing and able to provide informed consent in English.
  • Willing to comply with all study procedures and be available for the duration of the study.
  • Younger Community Group: Generally healthy children 12 to 36 months of age at the time of enrollment
  • Older Community Group: Generally healthy children 5 to 17.5 years of age at the time of enrollment.
  • Current patient within primary care system at UW Health

Inclusion Criteria (Aim 2a: Hospitalized Group):

  • Parent/legal guardian is willing and able to provide informed consent in English.
  • Admitted to American Family Children's Hospital (AFCH) within the past 24 hours
  • Children under 17.5 years of age at the time of enrollment
  • Has a diagnosis of bronchiolitis, asthma exacerbation, acute hypoxemic respiratory failure or community acquired pneumonia (CAP) OR is an infant less than 6 months of age with fever greater than 38 degrees Celsius within 24 hours of hospital admission

Exclusion Criteria (all participants):

  • Congenital or currently acquired immunosuppressive condition or medications (e.g., congenital immunodeficiency, Leukemia, Lupus)
  • Congenital anomalies that might alter frequency of infection (e.g., unrepaired cleft palate, bronchial cyst, pulmonary sequestration)
  • Presence of tracheostomy or gastrostomy tube
  • Previously enrolled a different group in the study
  • Other child in the same household already enrolled in the study
  • Not suitable for study participation due to other reasons at the discretion of the investigators.

Exclusion Criteria (Aim 1: Community Group Only):

  • History of chronic pulmonary diseases (e.g., asthma, cystic fibrosis, bronchopulmonary dysplasia (BPD)) (Note: asthma IS exclusionary)
  • Acute upper respiratory symptoms within the past week (7 days) at the time of enrollment

Exclusion Criteria (Aim 2: Hospitalized Group Only):

  • History of chronic pulmonary diseases, excluding asthma (e.g., cystic fibrosis, bronchopulmonary dysplasia (BPD)) (Note: asthma is NOT exclusionary)
  • A positive test for any virus other than RV within the 48 hours prior to and including admission.
  • Non-respiratory infection at the time of admission
  • Neurologic disease (for example, cerebral palsy, genetic neurologic diseases, seizure disorder)

Exclusion Criteria (less than 5 years old only (All participants in Aim 1 and some participants in Aim 2a):

  • Born prematurely, less than 32 weeks 0 days gestational age

Study Design

Enrollment

670 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

Older Community Cohort (5 to 17.5 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

Interventions

Nasal Swab Healthy Surveillance

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

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

2 nasal swabs collected upon consent, one anterior and one mid-turbinate

Sick Follow-up Survey

Caregivers are surveyed 7-13 days after sick sample collection

Older Cohort Control Group

Participants will be enrolled as needed based on enrollment of hospitalized patients

Procedural Comfort or Care

For hospitalized participants who opt to induce sputum, 3 medications will be used to obtain the sample, albuterol sulfate solution and hypertonic saline (3% solution) administered via nebulizer and and lidocaine spray (4% solution) via atomizer to the nose. For hospitalized participants with pneumonia who opt for research blood draw or induced sputum, optional administration of oral sucrose (Sweet-Ease) may occur at the discretion of the treating provider.

Primary outcome measure

  • Aim 1: Summary of Rhinovirus Types Identified in Community Cohort [ Time Frame: data collected up to 36 months ]
  • Aim 1: Unique Nasal Transcriptomic Signature of Clinical Rhinovirus Infections [ Time Frame: data collected up to 36 months ]

Central Contacts and Locations

Central contacts

Research Nurses

608-228-4940reserachnurses@pediatrics.wisc.edu

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Aug 10, 2026

Last verified

Jul, 2026

Keywords

  • infants
  • children
  • symptomatic
  • asymptomatic
  • lower respiratory tract infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-08-10.