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

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ClinicalTrials.gov Identifier: NCT00593918
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : May 13, 2010
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease
Respiratory Syncytial Virus Infection

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.

Study Type : Observational
Actual Enrollment : 91 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Innate Immunity and RSV Infection in Children
Study Start Date : November 2003
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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
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



Primary Outcome Measures :
  1. Nasal Interferon (IFN)-a2 [ Time Frame: 1-5 days during acute illness (not after day 5 of illness) ]
    Interferon a2 was measured from nasal lavage samples by Luminex multiplex assay.

  2. 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) ]
    IL-2 measured from nasal lavage samples by Luminex multiplex assay


Biospecimen Retention:   Samples With DNA
Nasal samples Supernatant from Peripheral mononuclear cell stimulation cultures DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593918


Locations
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792-9988
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Theresa W. Guilbert, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00593918     History of Changes
Other Study ID Numbers: 7K08HL071742-05 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2008    Key Record Dates
Results First Posted: May 13, 2010
Last Update Posted: October 20, 2015
Last Verified: September 2015

Keywords provided by University of Wisconsin, Madison:
RSV, asthma, innate immunity, gene, cytokines

Additional relevant MeSH terms:
Infection
Communicable Diseases
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections