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

Completed

• Conditions: Invasive Pneumococcal Disease, Recurrent Isolated, 1; Invasive Pneumococcal Disease, Recurrent Isolated, 2; Primary Immunodeficiency; Invasive Pneumococcal Disease, Protection Against
• Interventions: Other: Referral to Immunology

• Registration Number: NCT03815357
• Lead Sponsor: Murdoch Childrens Research Institute

Brief Summary

This is a multicentre prospective audit to determine the incidence of immunodeficiency in children with IPD.

Aims and/or research question of the project

1. To determine the incidence of primary immunodeficiency in children \>2 years who present with IPD

2. To determine the types of immunodeficiency associated with IPD in children

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-31
• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2019-01-20
• Study First Posted: 2019-01-24
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with IPD	Referral to Immunology	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.

Primary Outcome Measures

Name	Time	Method
types of immunodeficiency associated with children who present with invasive pneumococcal disease	3 years	This will be determined based on the testing performed by the immunologists.
incidence of primary immunodeficiency in children who present with invasive pneumococcal disease	3 years	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.

Secondary Outcome Measures

Name	Time	Method
whether increased referrals of children who present with invasive pneumococcal disease for investigation of primary immunodeficiency facilitates early detection	3 years	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.

Trial Locations

Locations (6)

Lady Cilento Children's Hospital; 🇦🇺 Brisbane, Australia

Sydney Children's Hospital; 🇦🇺 Sydney, New South Wales, Australia

Adelaide Women's and Children's Hospital; 🇦🇺 Adelaide, South Australia, Australia

Monash Health; 🇦🇺 Clayton, Victoria, Australia

Royal Children's Hospital; 🇦🇺 Melbourne, Victoria, Australia

Capital and Coast District Health Board; 🇳🇿 Wellington, New Zealand