BronchiolitisNCT01159795
Studying Innate Immune Responses in Infants With Bronchiolitis
An observational study of Bronchiolitis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study aims to establish whether impaired innate immune responses are associated with severity of Respiratory syncytial virus (RSV) infection. Read more about this study
- Who is it for?
- Ages 6 weeks to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 weeks to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants presenting with bronchiolitis presenting to St Mary's Hospital, London
Who may be able to join
- Bronchiolitis
- Infant
Who cannot join
- Age over 1 year
- Underlying chronic lung disease, prematurity, congenital heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Type I and Type III Interferon Responses in Infants With Respiratory Syncytial Virus
This study aims to establish whether impaired innate immune responses are associated with severity of Respiratory syncytial virus (RSV) infection.
Read the 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.
- Conditions
- Bronchiolitis
- Keywords
- Respiratory Syncytial Virus, Infant, Interferon
- Medical subject headings
- Bronchiolitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At presentation (average = day 4 of symptoms)
Secondary outcomes (1)
RSV viral load
RSV viral load will be measured by quantitataive real-time PCR on nasal epithelium samples.
Measured: At presentation (average = day 4 of symptoms)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Awaiting further funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Levin, FMed Sci, Principal investigator, Department of Paediatrics, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159795
- Sponsor's protocol ID
- 10/H0707/24
- Status last verified
- Apr 2012
- First submitted
- 6 Jul 2010
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Type I and Type III Interferon Responses in Infants With Respiratory Syncytial Virus
- ClinicalTrials.gov ID
- NCT01159795
- Acronym / sponsor ID
- 10/H0707/24
- Conditions
- Bronchiolitis
- Keywords
- Respiratory Syncytial Virus, Infant, Interferon
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Awaiting further funding
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to establish whether impaired innate immune responses are associated with severity of Respiratory syncytial virus (RSV) infection.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 weeks to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants presenting with bronchiolitis presenting to St Mary's Hospital, London
Key inclusion criteria (2 listed)
- Bronchiolitis
- Infant
Key exclusion criteria (2 listed)
- Age over 1 year
- Underlying chronic lung disease, prematurity, congenital heart disease
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 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.
1 secondary outcome
RSV viral load
Time frame: At presentation (average = day 4 of symptoms)
Results and safety
The study was stopped early (reason given: Awaiting further funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
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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.
Michael Levin, FMed Sci principal investigator
Department of Paediatrics, Imperial College London
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 Bronchiolitis, run by Imperial College London at 1 site in United Kingdom.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 11 Nov 2016. 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 Kingdom. 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?
The study was stopped early (reason given: Awaiting further funding). Results are not available in the source record.
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 and blood interferon alpha, beta, lambda levels(protein level and gene expression) (time frame: At presentation (average = day 4 of symptoms)). 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 11 Nov 2016.