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

NCT ID: NCT00593918

Last Updated: 2015-10-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 91 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2008-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Respiratory Syncytial Virus Infection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Toll-like Receptor 4 -2026/GG Genotype

Toll-like Receptor 4 (TLR4) -2026/GG Genotype of interest hypothesized to be associated with less inflammation during Respiratory Syncytial virus (RSV) infection

No interventions assigned to this group

Toll-like Receptor 4 -2026/AG and AA Genotypes

Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during respiratory syncytial virus (RSV) infection

No interventions assigned to this group

Eligibility 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.

• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theresa W. Guilbert, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin-Madison

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

7K08HL071742-05

Identifier Type: NIH

Identifier Source: org_study_id

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