RhinovirusNCT07342582
The Rhinovirus Hospitalization and Investigation of Nasal-airway Omics (RHINO) Study
An observational study of Rhinovirus, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinovirus
- What is being tested?
- Nasal Swab Healthy Surveillance, Nasal Swab Sick Samples and Nasal Swab Hospitalized Cohort
- Type of treatment
- Pill or oral medicine
- How many people
- 670 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2026to May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Aim 1: Generally healthy male and female children 12 to 36 months of age living in Dane County and surrounding areas representative of the general demographics of the county. Aim 2a: Hospitalized male and female children between newborn and 17.5 years of age with acute onset lower respiratory tract infections. These children will span all demographic and socioeconomic groups. Aim 2b: Generally healthy male and female children 5 to 17.5 years of age living in Dane County and surrounding areas representative of the general demographics of the county.
Who may be able to join
- 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
- Parent/legal guardian is willing and able to provide informed consent in English.
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- 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
Who cannot join
- 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.
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- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53792
About this study
Official title: Identifying the Burden of Hospitalization Due to Rhinovirus (RV) in Children and Mechanisms of Pathogenesis Using Airway Molecular Profiling
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.
Read the detailed description
Aim 1: Involves the prospective creation of a cohort of generally healthy children 12 to 36 months to be followed longitudinally for 36 months in an observational study. To determine the frequency of virus infection with RV and other respiratory viruses, children will have two swabs of the nasal mucosa performed whenever they develop an acute respiratory illness (upper respiratory symptoms lasting more than 24 hours) and four times a year for surveillance. One swab will be of the anterior nose and will be used for identification of viruses, and a second mid-turbinate swab will be used for host transcriptomics. This will allow the investigators to create many samples from both symptomatic and asymptomatic infections. The samples will be used to develop a host signature to discriminate symptomatic and asymptomatic infection.
Aim 2a: Involves the evaluation of generally healthy children hospitalized at AFCH with acute, lower respiratory tract infections including bronchiolitis, asthma, acute hypoxemic respiratory failure and community acquired pneumonia. There will also be the evaluation of infants less than 6 months of age who may become ill with an RV syndrome. These children will be evaluated with two nasal swabs as above. This allows the identification of children infected with RV and other respiratory viruses. Application of the host signature developed in Aim 1 will determine the actual proportion of those children who are infected with RV whose illness (clinical symptoms) is caused by RV.
Aim 2b: Involves the prospective creation of a cohort of generally healthy children 5 to 17.5 years old to be sampled on an as-needed basis to serve as age- and season-matched controls for the Hospitalized Group. To determine the frequency of virus infection with RV and other respiratory viruses, 2 healthy children will provide a single swab of the nasal mucosa within 2 weeks of each hospitalized participant who is 5-17.5 years of age. The one swab will be of the anterior nose and will be used for identification of viruses. Age matching will occur within 3 groups:
- Ages 5-8 years old: n=50
- Ages 9-13 years old: n=30
- Ages 14-17.5 years old: n=20
Aim 3: Use parallel bulk and single cell RNA sequencing (scRNA-seq) to identify targetable processes of acute, severe LRT caused by RV. The investigators hypothesize that integrated bulk RNA-sequencing and scRNA-seq will identify immune/inflammatory defects and targets for intervention. Bulk and scRNA-seq on respiratory samples from well-characterized patients with severe RV disease will be performed to test this hypothesis and to compare samples obtained from those with non-severe disease.
- Conditions
- Rhinovirus
- Being tested
- Nasal Swab Healthy Surveillance, Nasal Swab Sick Samples, Nasal Swab Hospitalized Cohort, Sick Follow-up Survey, Older Cohort Control Group
- Keywords
- infants, children, symptomatic, asymptomatic, lower respiratory tract infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Swab Healthy SurveillanceDiagnostic 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 SamplesDiagnostic 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 CohortDiagnostic test
2 nasal swabs collected upon consent, one anterior and one mid-turbinate
Sick Follow-up SurveyOther
Caregivers are surveyed 7-13 days after sick sample collection
Older Cohort Control GroupOther
Participants will be enrolled as needed based on enrollment of hospitalized patients
Procedural Comfort or CareOther
Also called Albuterol sulfate solution, Hypertonic saline, Lidocaine spray, Sweet-Ease
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Nasal Swab Healthy Surveillance; Diagnostic Test: Nasal Swab Sick Samples; Other: Sick Follow-up Survey | |
| 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 Receives: Diagnostic Test: Nasal Swab Hospitalized Cohort; Other: Procedural Comfort or Care | |
| 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 Receives: Other: Older Cohort Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: Summary of Rhinovirus Types Identified in Community Cohort
To test study hypotheses, the study team will identify the circulating RV types in symptomatic and asymptomatic children.
Measured: data collected up to 36 months
Aim 1: Unique Nasal Transcriptomic Signature of Clinical Rhinovirus Infections
Measured: data collected up to 36 months
Secondary outcomes (2)
Aim 2: Summary of Rhinovirus Types Identified in lower respiratory tract (LRT) infections and upper respiratory tract infections (URI), Reported as Percent in Common
To test the hypothesis that there will be an 80 percent overlap between RV types causing acute LRT and URI, investigators will compare all RV types identified in age-matched hospitalized and ambulatory children.
Measured: data collected up to 36 months
Aim 2: Proportion of Hospitalized Cohort with lower respiratory infections attributable to Rhinovirus
The investigators will use host nasal transcriptomics derived from symptomatic and asymptomatic children with RV infection to determine the proportion of age-matched hospitalized LRT infections actually attributable to RV.
Measured: data collected up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start4 Aug 2026
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinovirusStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen R Wald, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342582
- Sponsor's protocol ID
- 2025-1076
- Other IDs
- Protocol Version 7/7/26, SMPH\PEDIATRICS\INFECT DIS, 1R01AI182200-01A1
- Status last verified
- Jul 2026
- First submitted
- 13 Jan 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will comply with the NIH Genomic Data Sharing Policy, which applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Burden of Hospitalization Due to Rhinovirus (RV) in Children and Mechanisms of Pathogenesis Using Airway Molecular Profiling
- ClinicalTrials.gov ID
- NCT07342582
- Acronym / sponsor ID
- 2025-1076
- Conditions
- Rhinovirus
- Keywords
- infants, children, symptomatic, asymptomatic, lower respiratory tract infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim 1: Involves the prospective creation of a cohort of generally healthy children 12 to 36 months to be followed longitudinally for 36 months in an observational study. To determine the frequency of virus infection with RV and other respiratory viruses, children will have two swabs of the nasal mucosa performed whenever they develop an acute respiratory illness (upper respiratory symptoms lasting more than 24 hours) and four times a year for surveillance. One swab will be of the anterior nose and will be used for identification of viruses, and a second mid-turbinate swab will be used for host transcriptomics. This will allow the investigators to create many samples from both symptomatic and asymptomatic infections. The samples will be used to develop a host signature to discriminate symptomatic and asymptomatic infection.
Aim 2a: Involves the evaluation of generally healthy children hospitalized at AFCH with acute, lower respiratory tract infections including bronchiolitis, asthma, acute hypoxemic respiratory failure and community acquired pneumonia. There will also be the evaluation of infants less than 6 months of age who may become ill with an RV syndrome. These children will be evaluated with two nasal swabs as above. This allows the identification of children infected with RV and other respiratory viruses. Application of the host signature developed in Aim 1 will determine the actual proportion of those children who are infected with RV whose illness (clinical symptoms) is caused by RV.
Aim 2b: Involves the prospective creation of a cohort of generally healthy children 5 to 17.5 years old to be sampled on an as-needed basis to serve as age- and season-matched controls for the Hospitalized Group. To determine the frequency of virus infection with RV and other respiratory viruses, 2 healthy children will provide a single swab of the nasal mucosa within 2 weeks of each hospitalized participant who is 5-17.5 years of age. The one swab will be of the anterior nose and will be used for identification of viruses. Age matching will occur within 3 groups:
- Ages 5-8 years old: n=50
- Ages 9-13 years old: n=30
- Ages 14-17.5 years old: n=20
Aim 3: Use parallel bulk and single cell RNA sequencing (scRNA-seq) to identify targetable processes of acute, severe LRT caused by RV. The investigators hypothesize that integrated bulk RNA-sequencing and scRNA-seq will identify immune/inflammatory defects and targets for intervention. Bulk and scRNA-seq on respiratory samples from well-characterized patients with severe RV disease will be performed to test this hypothesis and to compare samples obtained from those with non-severe disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Younger Community Cohort (12-36 months of age) | – | Diagnostic Test: Nasal Swab Healthy Surveillance, Diagnostic Test: Nasal Swab Sick Samples, Other: Sick Follow-up SurveyQuarterly 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 | – | Diagnostic Test: Nasal Swab Hospitalized Cohort, Other: Procedural Comfort or CareGenerally 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) | – | Other: Older Cohort Control GroupAge-matched controls for older children in the Hospitalized Group, will be called upon as needed based on enrollment of hospitalized patients |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Aim 1: Generally healthy male and female children 12 to 36 months of age living in Dane County and surrounding areas representative of the general demographics of the county. Aim 2a: Hospitalized male and female children between newborn and 17.5 years of age with acute onset lower respiratory tract infections. These children will span all demographic and socioeconomic groups. Aim 2b: Generally healthy male and female children 5 to 17.5 years of age living in Dane County and surrounding areas representative of the general demographics of the county.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal Swab Healthy SurveillanceFamilies 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. | Diagnostic test | Younger Community Cohort (12-36 months of age) |
| Nasal Swab Sick SamplesCaregivers 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 | Diagnostic test | Younger Community Cohort (12-36 months of age) |
| Nasal Swab Hospitalized Cohort2 nasal swabs collected upon consent, one anterior and one mid-turbinate | Diagnostic test | Hospitalized Cohort of Infants and Children |
| Sick Follow-up SurveyCaregivers are surveyed 7-13 days after sick sample collection | Other | Younger Community Cohort (12-36 months of age) |
| Older Cohort Control GroupParticipants will be enrolled as needed based on enrollment of hospitalized patients | Other | Older Community Cohort (5 to 17.5 years of age) |
| Procedural Comfort or CareAlso: Albuterol sulfate solution, Hypertonic saline, Lidocaine spray, Sweet-EaseFor 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. | Other | Hospitalized Cohort of Infants and Children |
Primary outcome
Aim 1: Summary of Rhinovirus Types Identified in Community Cohort
Time frame: data collected up to 36 months
To test study hypotheses, the study team will identify the circulating RV types in symptomatic and asymptomatic children.
Aim 1: Unique Nasal Transcriptomic Signature of Clinical Rhinovirus Infections
Time frame: data collected up to 36 months
2 secondary outcomes
Aim 2: Summary of Rhinovirus Types Identified in lower respiratory tract (LRT) infections and upper respiratory tract infections (URI), Reported as Percent in Common
Time frame: data collected up to 36 months
Aim 2: Proportion of Hospitalized Cohort with lower respiratory infections attributable to Rhinovirus
Time frame: data collected up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. This study will comply with the NIH Genomic Data Sharing Policy, which applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellen R Wald, MD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinovirus, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Nurses (608-228-4940, reserachnurses@pediatrics.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Summary of Rhinovirus Types Identified in Community Cohort (time frame: data collected up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.