What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)?

Study Overview
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Brief Summary
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This is a multicentre prospective audit to determine the incidence of immunodeficiency in children with IPD. Aims and/or research question of the project To determine the incidence of primary immunodeficiency in children >2 years who present with IPD To determine the types of immunodeficiency associated with IPD in children

Official Title
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What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)? A Prospective Cohort Study.

Conditions
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Invasive Pneumococcal Disease, Recurrent Isolated, 1, Invasive Pneumococcal Disease, Recurrent Isolated, 2, Invasive Pneumococcal Disease, Protection Against, Primary Immunodeficiency

Intervention / Treatment
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* Other: Referral to Immunology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 0 to 18 years admitted to one of the six centres with IPD. Exclusion Criteria: Children who do not fulfil the age criteria for immunological evaluation at that particular site e.g. aged <2 years at Royal Children's Hospital. Children with a known underlying condition predisposing to IPD i.e. nephrotic syndrome.

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with IPD<br>Children with IPD will be referred for immunological evaluation. The protocol for immune work up will be the same but between centres there is variation in the age criteria for referral i.e. >2 years in some, >6 months in others. | Other: Referral to Immunology<br>* Screening for primary immunodeficiency including splenic dysfunction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of primary immunodeficiency in children who present with invasive pneumococcal disease | This will be picked up upon prospective immunological testing, after identification of patients with invasive pneumococcal disease. A series of tests will be performed depending on the clinical opinion of the immunology team. Such tests may include lymphocyte subsets, complement function, serum immunoglobulin levels, memory B cells, vaccine antibody responses, etc. | 3 years | 
| types of immunodeficiency associated with children who present with invasive pneumococcal disease | This will be determined based on the testing performed by the immunologists. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whether increased referrals of children who present with invasive pneumococcal disease for investigation of primary immunodeficiency facilitates early detection | This information will come from reviewing the case series of patients who are identified from this study. The incidence of those with primary immunodeficiency will be analysed against known background rates of diagnoses. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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streptococcus pneumoniae, invasive pneumococcal disease, primary immunodeficiency