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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03815357
Enrollment
380
Registered
2019-01-24
Start date
2017-01-31
Completion date
2021-06-30
Last updated
2022-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

streptococcus pneumoniae, invasive pneumococcal disease, primary immunodeficiency

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

Interventions

OTHERReferral to Immunology

Screening for primary immunodeficiency including splenic dysfunction

Sponsors

Royal Children's Hospital
CollaboratorOTHER
Murdoch Childrens Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Months to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
incidence of primary immunodeficiency in children who present with invasive pneumococcal disease3 yearsThis 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.
types of immunodeficiency associated with children who present with invasive pneumococcal disease3 yearsThis will be determined based on the testing performed by the immunologists.

Secondary

MeasureTime frameDescription
whether increased referrals of children who present with invasive pneumococcal disease for investigation of primary immunodeficiency facilitates early detection3 yearsThis 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.

Countries

Australia, New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026