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

Respiratory Syncytial Virus Infection Clinical Trial

— IIRI  

Official title:

Innate Immunity and RSV Infection in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593918
• Other study ID #: 7K08HL071742-05
• Status: Completed
• Phase: N/A
• First received: January 3, 2008
• Last updated: September 30, 2015
• Start date: November 2003
• Est. completion date: June 2008

Study information

• Verified date: September 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Respiratory Syncytial Virus Infection
• Respiratory Syncytial Virus Infections
• Virus Diseases

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal Interferon (IFN)-a2	Interferon a2 was measured from nasal lavage samples by Luminex multiplex assay.	1-5 days during acute illness (not after day 5 of illness)	No
Primary	Percentage of Participants With Detected Nasal Interferon (IL)-2 Cytokine Expression	IL-2 measured from nasal lavage samples by Luminex multiplex assay	1-5 days during acute illness (not after day 5 of illness)	No

External Links

•   More information about this and other pediatric asthma studies at UW-Madison