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Studying Innate Immune Responses in Infants With Bronchiolitis

This study has been terminated.
(Awaiting further funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01159795
First Posted: July 9, 2010
Last Update Posted: November 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Imperial College London
  Purpose
This study aims to establish whether impaired innate immune responses are associated with severity of Respiratory syncytial virus (RSV) infection.

Condition
Bronchiolitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Type I and Type III Interferon Responses in Infants With Respiratory Syncytial Virus

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Nasal and blood interferon alpha, beta, lambda levels(protein level and gene expression) [ Time Frame: At presentation (average = day 4 of symptoms) ]
    Interferon alpha, beta and lambda protein levels will be measured by ELISA and gene expression by quantitative real-time PCR, on paired nasal and blood samples.


Secondary Outcome Measures:
  • RSV viral load [ Time Frame: At presentation (average = day 4 of symptoms) ]
    RSV viral load will be measured by quantitataive real-time PCR on nasal epithelium samples.


Biospecimen Retention:   Samples With DNA
Blood plasma - cytokines Blood EDTA - DNA Blood PAXgene tube - RNA Nasal lining fluid - cytokines Nasal mucosal lining - RNA

Enrollment: 250
Study Start Date: October 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Respiratory syncytial virus (RSV) causes a spectrum of illness in healthy infants, ranging from asymptomatic infection to life threatening bronchiolitis with respiratory failure. The reasons for the differences in clinical presentation remain unknown. Interferons are natural antiviral factors and components of the innate immune response, which play a role in limiting viral replication.

We postulate that differences in clinical severity of RSV infection may be due to innate immune differences in the production of type I and III interferons (innate interferons). To test this hypothesis, we will recruit infants with mild, moderate and severe RSV bronchiolitis and compare production of innate interferons in blood and respiratory samples, using quantitative and functional analysis. We will determine whether interferon responses differ across a spectrum of clinical severity, and will relate them to viral load.

To establish whether defects in interferon production persist in those infants with severe infection, we will retest them following recovery and measure interferon responses after challenge with live RSV. Demonstrating a persisting defect may suggest a genetically determined defect requiring further investigation. Identification of the mechanisms of severe disease in patients without known risk-factors could lead to targeted therapy to prevent or treat severe disease.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Infants presenting with bronchiolitis presenting to St Mary's Hospital, London
Criteria

Inclusion Criteria:

  • Bronchiolitis
  • Infant

Exclusion Criteria:

  • Age over 1 year
  • Underlying chronic lung disease, prematurity, congenital heart disease
  Contacts and Locations
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): NCT01159795


Locations
United Kingdom
St Mary's Hospital
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Michael Levin, FMed Sci Department of Paediatrics, Imperial College London
  More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01159795     History of Changes
Other Study ID Numbers: 10/H0707/24
First Submitted: July 6, 2010
First Posted: July 9, 2010
Last Update Posted: November 11, 2016
Last Verified: April 2012

Keywords provided by Imperial College London:
Respiratory Syncytial Virus
Infant
Interferon

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents