Expired Study
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Madison, Wisconsin 53792


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: 1. Parental or sibling history of asthma. 2. Child must be less than 24 months of age. 3. Presence of viral upper or lower respiratory tract symptoms. Exclusion Criteria: 1. History of recurrent wheezing requiring systemic corticosteroids. 2. Prior history of lung disease. 3. Birth < 36 weeks gestation. 4. Immunodeficiency 5. Treatment with ribavirin, systemic or inhaled corticosteroids during the RSV infection. 6. Congenital heart disease. 7. No history of parental or sibling asthma. 8. Less than 48 hour or more than 5 day duration of viral URI symptoms since the peak symptoms from RSV would be expected to occur from 2-5 days into course of infection.


Study is Available At:


Original ID:

7K08HL071742-05


NCT ID:

NCT00593918


Secondary ID:


Study Acronym:

IIRI


Brief Title:

Innate Immunity and Respiratory Syncytial Virus (RSV) Infection in Children


Official Title:

Innate Immunity and RSV Infection in Children


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

24 Months


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Wisconsin, Madison


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspecti


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

91


Enrollment Type:

Actual


Overall Contact Information

Official Name:Theresa W. Guilbert, MD
Principal Investigator
University of Wisconsin, Madison

Study Dates

Start Date:November 2003
Completion Date:June 2008
Completion Type:Actual
Primary Completion Date:May 2008
Primary Completion Type:Actual
Verification Date:July 2010
Last Changed Date:July 20, 2010
First Received Date:January 3, 2008
First Results Date:June 19, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Nasal Interferon (IFN)-a2
Time Frame:1-5 days during acute illness (not after day 5 of illness)
Safety Issues:False
Description:Interferon a2 was measured from nasal lavage samples by Luminex multiplex assay.
Outcome Type:Primary Outcome
Measure:Percentage of Participants With Detected Nasal Interferon (IL)-2 Cytokine Expression
Time Frame:1-5 days during acute illness (not after day 5 of illness)
Safety Issues:False
Description:IL-2 measured from nasal lavage samples by Luminex multiplex assay

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Toll-like Receptor 4 -2026/GG Genotype
Description:Toll-like Receptor 4 (TLR4) -2026/GG Genotype of interest hypothesized to be associated with less inflammation during Respiratory Syncytial virus (RSV) infection
Study Arm Type:Other
Arm Name:Toll-like Receptor 4 -2026/AG and AA Genotypes
Description:Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during respiratory syncytial virus (RSV) infection

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Wisconsin, Madison

Samples and Retentions

Sample Retention:Samples With DNA
Description: Nasal samples Supernatant from Peripheral mononuclear cell stimulation cultures DNA
Study Population: 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.
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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