Studying Innate Immune Responses in Infants With Bronchiolitis

This study has suspended participant recruitment.
(Awaiting further funding)
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01159795
First received: July 6, 2010
Last updated: April 23, 2012
Last verified: April 2012
  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

Resource links provided by NLM:


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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 250
Study Start Date: October 2010
Estimated Study Completion Date: March 2013
Estimated 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

Ages Eligible for Study:   6 Weeks to 1 Year
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01159795     History of Changes
Other Study ID Numbers: 10/H0707/24
Study First Received: July 6, 2010
Last Updated: April 23, 2012
Health Authority: United Kingdom: Research Ethics Committee

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
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 23, 2014