Understanding Childhood Infection, Inflammation and Allergy

NCT01022268 | Completed Results

• 1 other identifier: CRO1330
• Study Type: observational
• Target: 902
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Inflammation; Allergy; Children

Keywords

Inflammation; Children; Observational

Outcome Measures

Primary Outcomes (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?

  number of participants with phenotype of definite bacterial or definite viral disease, based on culture or molecular investigations of samples from a sterile site

  Participants were monitored for outcome throughout their stay in hospital, and received follow-up review at 10 days

Study Arms (2)

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

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead
• University Hospital Southampton NHS Foundation Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (1)

St Mary's Hospital, Paddington

London, W2 1NY, United Kingdom

Location

Related Publications (8)

• Cebey-Lopez M, Herberg J, Pardo-Seco J, Gomez-Carballa A, Martinon-Torres N, Salas A, Martinon-Sanchez JM, Gormley S, Sumner E, Fink C, Martinon-Torres F; GENDRES network. Viral Co-Infections in Pediatric Patients Hospitalized with Lower Tract Acute Respiratory Infections. PLoS One. 2015 Sep 2;10(9):e0136526. doi: 10.1371/journal.pone.0136526. eCollection 2015.

  PMID: 26332375 BACKGROUND

• Cebey-Lopez M, Herberg J, Pardo-Seco J, Gomez-Carballa A, Martinon-Torres N, Salas A, Martinon-Sanchez JM, Justicia A, Rivero-Calle I, Sumner E, Fink C, Martinon-Torres F; GENDRES network. Does Viral Co-Infection Influence the Severity of Acute Respiratory Infection in Children? PLoS One. 2016 Apr 20;11(4):e0152481. doi: 10.1371/journal.pone.0152481. eCollection 2016.

  PMID: 27096199 BACKGROUND

• Kaforou M, Herberg JA, Wright VJ, Coin LJM, Levin M. Diagnosis of Bacterial Infection Using a 2-Transcript Host RNA Signature in Febrile Infants 60 Days or Younger. JAMA. 2017 Apr 18;317(15):1577-1578. doi: 10.1001/jama.2017.1365. No abstract available.

  PMID: 28418473 BACKGROUND

• Wang X, Nijman R, Camuzeaux S, Sands C, Jackson H, Kaforou M, Emonts M, Herberg JA, Maconochie I, Carrol ED, Paulus SC, Zenz W, Van der Flier M, de Groot R, Martinon-Torres F, Schlapbach LJ, Pollard AJ, Fink C, Kuijpers TT, Anderson S, Lewis MR, Levin M, McClure M; EUCLIDS consortium. Plasma lipid profiles discriminate bacterial from viral infection in febrile children. Sci Rep. 2019 Nov 27;9(1):17714. doi: 10.1038/s41598-019-53721-1.

  PMID: 31776453 BACKGROUND

• Herberg JA, Kaforou M, Gormley S, Sumner ER, Patel S, Jones KD, Paulus S, Fink C, Martinon-Torres F, Montana G, Wright VJ, Levin M. Transcriptomic profiling in childhood H1N1/09 influenza reveals reduced expression of protein synthesis genes. J Infect Dis. 2013 Nov 15;208(10):1664-8. doi: 10.1093/infdis/jit348. Epub 2013 Jul 29.

  PMID: 23901082 RESULT

• Herberg JA, Jones KD, Paulus S, Gormley S, Muir D, Cooper M, Levin M. Comparison of pandemic and seasonal influenza reveals higher mortality and increased prevalence of shock in children with severe h1n1/09 infection. Pediatr Infect Dis J. 2011 May;30(5):438-40. doi: 10.1097/INF.0b013e3182040c90.

  PMID: 21102362 RESULT

• Herberg JA, Kaforou M, Wright VJ, Shailes H, Eleftherohorinou H, Hoggart CJ, Cebey-Lopez M, Carter MJ, Janes VA, Gormley S, Shimizu C, Tremoulet AH, Barendregt AM, Salas A, Kanegaye J, Pollard AJ, Faust SN, Patel S, Kuijpers T, Martinon-Torres F, Burns JC, Coin LJ, Levin M; IRIS Consortium. Diagnostic Test Accuracy of a 2-Transcript Host RNA Signature for Discriminating Bacterial vs Viral Infection in Febrile Children. JAMA. 2016 Aug 23-30;316(8):835-45. doi: 10.1001/jama.2016.11236.

  PMID: 27552617 RESULT

• Wright VJ, Herberg JA, Kaforou M, Shimizu C, Eleftherohorinou H, Shailes H, Barendregt AM, Menikou S, Gormley S, Berk M, Hoang LT, Tremoulet AH, Kanegaye JT, Coin LJM, Glode MP, Hibberd M, Kuijpers TW, Hoggart CJ, Burns JC, Levin M; Immunopathology of Respiratory, Inflammatory and Infectious Disease Study (IRIS) Consortium and the Pediatric Emergency Medicine Kawasaki Disease Research Group (PEMKDRG). Diagnosis of Kawasaki Disease Using a Minimal Whole-Blood Gene Expression Signature. JAMA Pediatr. 2018 Oct 1;172(10):e182293. doi: 10.1001/jamapediatrics.2018.2293. Epub 2018 Oct 1.

  PMID: 30083721 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum Plasma DNA RNA

MeSH Terms

Conditions

Infections; Inflammation; Hypersensitivity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Results Point of Contact

• Title: Dr Jethro Herberg
• Organization: Imperial College London

j.herberg@imperial.ac.uk

+44 - 0207 594 3990

Study Officials

• Michael Levin

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 1, 2009
• Study Start: July 20, 2009
• Primary Completion: August 30, 2018
• Study Completion: June 11, 2019
• Last Updated: November 21, 2022
• Results First Posted: November 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)