Respiratory Syncytial Virus InfectionIIRINCT00593918
Innate Immunity and Respiratory Syncytial Virus (RSV) Infection in Children
An observational study of Respiratory Syncytial Virus Infection, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infection
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Jun 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Parental or sibling history of asthma.
- Child must be less than 24 months of age.
- Presence of viral upper or lower respiratory tract symptoms.
Who cannot join
- History of recurrent wheezing requiring systemic corticosteroids.
- Prior history of lung disease.
- Birth < 36 weeks gestation.
- Immunodeficiency
- Treatment with ribavirin, systemic or inhaled corticosteroids during the RSV infection.
- Congenital heart disease.
- No history of parental or sibling asthma.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53792-9988
About this study
Official title: Innate Immunity and RSV Infection in Children
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.
Read the 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
- Keywords
- RSV, asthma, innate immunity, gene, cytokines
- Medical subject headings
- Respiratory Syncytial Virus Infections, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Interferon (IFN)-a2
Interferon a2 was measured from nasal lavage samples by Luminex multiplex assay.
Measured: 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
Measured: 1-5 days during acute illness (not after day 5 of illness)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startNov 2003
- Primary completionMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus InfectionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theresa W. Guilbert, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593918
- Sponsor's protocol ID
- 7K08HL071742-05
- Acronym
- IIRI
- Status last verified
- Sep 2015
- First submitted
- 3 Jan 2008
- Last updated
- 20 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innate Immunity and RSV Infection in Children
- ClinicalTrials.gov ID
- NCT00593918
- Acronym / sponsor ID
- IIRI / 7K08HL071742-05
- Conditions
- Respiratory Syncytial Virus Infection
- Keywords
- RSV, asthma, innate immunity, gene, cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 13 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Parental or sibling history of asthma.
- Child must be less than 24 months of age.
- Presence of viral upper or lower respiratory tract symptoms.
Key exclusion criteria (8 listed)
- History of recurrent wheezing requiring systemic corticosteroids.
- Prior history of lung disease.
- Birth < 36 weeks gestation.
- Immunodeficiency
- Treatment with ribavirin, systemic or inhaled corticosteroids during the RSV infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa W. Guilbert, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infection, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Interferon (IFN)-a2 (time frame: 1-5 days during acute illness (not after day 5 of illness)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.