NCT01159795

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

November 11, 2016

Status Verified

April 1, 2012

Enrollment Period

2.4 years

First QC Date

July 6, 2010

Last Update Submit

November 10, 2016

Conditions

Bronchiolitis

Keywords

Respiratory Syncytial VirusInfantInterferon

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • RSV viral load

    At presentation (average = day 4 of symptoms)

Eligibility Criteria

Age6 Weeks - 1 Year
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Infants presenting with bronchiolitis presenting to St Mary's Hospital, London

You may qualify if:

  • Bronchiolitis
  • Infant

You may not qualify if:

  • Age over 1 year
  • Underlying chronic lung disease, prematurity, congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Mary's Hospital

London, W2 1NY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood plasma - cytokines Blood EDTA - DNA Blood PAXgene tube - RNA Nasal lining fluid - cytokines Nasal mucosal lining - RNA

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Michael Levin, FMed Sci

    Department of Paediatrics, Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2010

First Posted

July 9, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

November 11, 2016

Record last verified: 2012-04

Locations

GB(1)