An observational study in Respiratory Syncytial Virus Infection, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged Up to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-20.
Sponsored by University of Wisconsin, Madison · Observational
In this project we will study the capacity for single nucleotide polymorphisms (SNP) in TLR4 gene to induce varying levels of inflammatory chemokine and cytokine production.
Infection with RSV is the most common cause of respiratory tract illnesses (LRIs) in the first 3 years of life. There are significant social and health care costs associated with RSV-LRIs. More than 3% of US children are hospitalized each year due to RSV and 500 die annually. Several longitudinal studies have also suggested that children who have RSV-LRIs are at substantially increased risk of developing asthma in the first 3 years after infection and bronchial hyperresponsiveness (BHR) many years after the primary infection. Mechanisms involved in RSV disease are not well understood. Recent reports suggest that RSV may initiate the innate immune response through the pattern recognition receptor, Toll like receptor-4 (TLR4). In this project we will study the capacity for single nucleotide polymorphisms (SNP) in TLR4 gene to induce varying levels of inflammatory chemokine and cytokine production. It has been suggested that such a mechanism may result in altered immune responses to RSV infection and different clinical outcomes. This research has direct application to improving our understanding of bronchiolitis in early childhood, particularly those factors that influence severity of the disease, and may have implications for possible therapy of patients with bronchiolitis in the future.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 91 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children who present with viral upper respiratory infections or bronchiolitis to their primary care physician. Upon consent, children willl have cheek samples for genotyping and nasal secretion samples to determine RSV infection.
Exclusion Criteria:
Toll-like Receptor 4 (TLR4) -2026/GG Genotype of interest hypothesized to be associated with less inflammation during Respiratory Syncytial virus (RSV) infection
Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during respiratory syncytial virus (RSV) infection
Nasal Interferon (IFN)-a2
Interferon a2 was measured from nasal lavage samples by Luminex multiplex assay.
Time frame: 1-5 days during acute illness (not after day 5 of illness)
Percentage of Participants With Detected Nasal Interferon (IL)-2 Cytokine Expression
IL-2 measured from nasal lavage samples by Luminex multiplex assay
Time frame: 1-5 days during acute illness (not after day 5 of illness)
Study details planned during the first 4 months of the study. Recruitment period began during the RSV seasons from November to May each year from 2003-2008 in medical clinics.
| Milestone | Toll-like Receptor 4 GG Genotype | Toll-like Receptor 4 AG/AA Genotypes |
|---|---|---|
| Started | 17 | 74 |
| Completed | 12 | 50 |
| Not completed | 5 | 24 |
| Withdrew: Withdrawal by subject | 5 | 24 |
Interferon a2 was measured from nasal lavage samples by Luminex multiplex assay.
| pg/ml | Toll-like Receptor 4 GG Genotype | Toll-like Receptor 4 AG/AA Genotypes |
|---|---|---|
| Nasal Interferon (IFN)-a2 | 10 ± 3 | 26 ± 31 |
IL-2 measured from nasal lavage samples by Luminex multiplex assay
| Percentage of Participants | Toll-like Receptor 4 GG Genotype | Toll-like Receptor 4 AG/AA Genotypes |
|---|---|---|
| Percentage of Participants With Detected Nasal Interferon (IL)-2 Cytokine Expression | 0 | 44 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Toll-like Receptor 4 GG Genotype | — | 0/17 (0%) | 0/17 (0%) |
| Toll-like Receptor 4 AG/AA Genotypes | — | 0/74 (0%) | 0/74 (0%) |
| Age, Categorical(Participants) | Toll-like Receptor 4 GG Genotype | Toll-like Receptor 4 AG/AA Genotypes | Total |
|---|---|---|---|
| <=18 years | 17 | 74 | 91 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Toll-like Receptor 4 GG Genotype | Toll-like Receptor 4 AG/AA Genotypes | Total |
|---|---|---|---|
| Mean | 0.78 ± 0.56 | 0.82 ± 0.54 | 0.82 ± 0.55 |
| Sex: Female, Male(Participants) | Toll-like Receptor 4 GG Genotype | Toll-like Receptor 4 AG/AA Genotypes | Total |
|---|---|---|---|
| Female | 7 | 32 | 39 |
| Male | 10 | 42 | 52 |
| Region of Enrollment(participants) | Toll-like Receptor 4 GG Genotype | Toll-like Receptor 4 AG/AA Genotypes | Total |
|---|---|---|---|
| United States | 17 | 74 | 91 |
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison