Studying Innate Immune Responses in Infants With Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

Investigating Type I and Type III Interferon Responses in Infants With Respiratory Syncytial Virus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01159795
• Other study ID #: 10/H0707/24
• Status: Terminated
• Phase: N/A
• First received: July 6, 2010
• Last updated: November 10, 2016
• Start date: October 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2012
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

This study aims to establish whether impaired innate immune responses are associated with severity of Respiratory syncytial virus (RSV) infection.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 1 Year

Eligibility

Inclusion Criteria:

• Bronchiolitis

• Infant

Exclusion Criteria:

• Age over 1 year

• Underlying chronic lung disease, prematurity, congenital heart disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchiolitis

Locations

Country	Name	City	State
United Kingdom	St Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal and blood interferon alpha, beta, lambda levels(protein level and gene expression)	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.	At presentation (average = day 4 of symptoms)	No
Secondary	RSV viral load	RSV viral load will be measured by quantitataive real-time PCR on nasal epithelium samples.	At presentation (average = day 4 of symptoms)	No