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Understanding Childhood Infection, Inflammation and Allergy

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ClinicalTrials.gov Identifier: NCT01022268
Recruitment Status : Recruiting
First Posted : December 1, 2009
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

This proposal represents a unified programme supported by both clinical and academic staff in the Departments of Paediatrics at Imperial College and St Mary's Hospital, Southampton Hospital and John Radcliffe Hospital (Oxford). St Mary's Hospital is the hub of a paediatric network for West London, and forms part of the Paediatric Intensive Care Network for the London region, with potential access to a population of 3 million children.

We aim to improve diagnosis and understanding of children with infectious, inflammatory and allergic conditions. Our study will establish well-characterised cohorts of patients with defined conditions, in whom microbiological and patient samples will be used to understand the contribution of genetic background, differential gene expression, proteomics and the pathogen type to the disease process.

Unwell children coming to hospital through any route will be invited to join the study. Entering the study will entail the child having blood taken for research purposes in addition to the clinically indicated tests. We will also recruit well (control) children who are having blood tests performed for elective purposes, such as surgery.

In addition, children presenting with an illness that is likely to have an infectious aetiology will also have samples collected for microbiological diagnosis. Those samples taken for ordinary diagnostic purposes (such as blood, urine, cerebrospinal fluid (CSF), bronchoalveolar lavage (BAL) fluid or nasal brushings for epithelial cell cultures) would also be used for state-of-the-art diagnostic techniques, in order to maximise the likelihood of confirming a microbiological diagnosis. Where healthy, uninfected children are having invasive procedures, such as lumbar punctures, we would aim to recruit these children as controls and collect biological samples such as CSF samples.

This bid addresses the need for translational research in paediatrics, by building on the world-class basic science and clinical paediatric base at Imperial College and St Mary's Hospital.


Condition or disease
Infection Inflammation Allergy Children

Detailed Description:

There is currently little understanding of the mechanisms by which respiratory infections can cause severe illness and death. The emergence of Influenza A subtype (H1N1) as a major cause of childhood severe illness in 2009 permitted further study of how this virus triggers severe disease, and how the inflammatory response to H1N1 differs from other infections. It is likely that host-mediated inflammatory processes triggered by the infecting agent contributes to severe illness. In addition, viral infection induces profound changes in the innate immune response to common bacterial pathogens, with increased bacterial colonisation of normally sterile lower airway. Thus both host and bacterial factors may contribute to lung damage in severe respiratory infection.

This study was initiated to identify the aetiology and immunopathologic mechanisms of childhood respiratory infection (Immunopathology of Respiratory Infection Study - IRIS), recruiting children with suspected respiratory infection or respiratory failure (and controls). This dataset will provide a unique resource for further study of disease mechanisms in children with a range of infections including H1N1/09 infection, Respiratory Syncytial Virus (RSV), Rhinovirus, other common respiratory viruses and severe bacterial infections.


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Study Type : Observational
Estimated Enrollment : 902 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Comprehensive, Long-term Integrated Programme to Study the Aetiology and Immunopathology of Childhood Infectious, Inflammatory and Allergic Disease, Using the Large Patient Base of Children Attending St Mary's Hospital, London
Actual Study Start Date : July 20, 2009
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Infection, inflammation or allergy

Children presenting via any means to St Mary's Hospital; this would include the A&E department, the general and infectious disease wards and the paediatric intensive care unit.

Children needing blood tests for any clinical reason Children who, in the clinical judgement of the doctor assessing them, have presented because of a condition consistent with an infectious, inflammatory or allergic process

controls
children who do not have an infectious, inflammatory or allergic condition, who anyway require blood tests for clinical reasons



Primary Outcome Measures :
  1. What are the bacterial and viral causes of acute illness in children presenting to a UK general hospital, tertiary paediatric infectious disease unit and paediatric intensive care unit? [ Time Frame: 3y ]
  2. What immunopathogenic mechanisms are involved in severe infection caused by specific bacterial and viral pathogens, and in inflammatory and allergic conditions? [ Time Frame: 5y ]

Biospecimen Retention:   Samples With DNA
Serum Plasma DNA RNA


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Unwell children coming to St Mary's Hospital, Southampton Hospital or John Radcliffe Hospital (Oxford) through any route (Emergency Department, wards, intensive care)
Criteria

Inclusion Criteria:

  • children presenting via any means to Hospital
  • children needing blood tests for any clinical reason
  • children who have presented because of a condition consistent with an infectious, inflammatory or allergic process

Exclusion Criteria:

  • aged 17 or older
  • children re-presenting with the same condition
  • concern that the study is not fully understood by the parent or guardian

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): NCT01022268


Contacts
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Contact: Jethro A Herberg, BA MBBS PhD +44 (0)20 7594 3990 jethro.herberg@imperial.ac.uk

Locations
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United Kingdom
St Mary's Hospital, Paddington Recruiting
London, United Kingdom, W2 1NY
Principal Investigator: Michael Levin         
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Michael Levin Imperial College London
  Study Documents (Full-Text)

Documents provided by Imperial College London:

Publications:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01022268     History of Changes
Other Study ID Numbers: CRO1330
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Imperial College London:
Inflammation
Children
Observational

Additional relevant MeSH terms:
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Infection
Hypersensitivity
Inflammation
Pathologic Processes
Immune System Diseases