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Completed

NCT Number: NCT03815357

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

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

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Key information

Conditions

Invasive Pneumococcal Disease, Recurrent Isolated, 1 Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn IRAK4 Deficiency Immune System Diseases Immunologic Deficiency Syndromes Invasive Pneumococcal Disease, Protection Against Invasive Pneumococcal Disease, Recurrent Isolated, 2 Primary Immunodeficiency Primary Immunodeficiency Diseases

Age range

0 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sydney Children's Hospital, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Referral to Immunology

Other

Screening for primary immunodeficiency including splenic dysfunction

Primary outcomes

  1. incidence of primary immunodeficiency in children who present with invasive pneumococcal disease

    Time frame: 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.

  2. types of immunodeficiency associated with children who present with invasive pneumococcal disease

    Time frame: 3 years

    This will be determined based on the testing performed by the immunologists.

Secondary outcomes

  1. whether increased referrals of children who present with invasive pneumococcal disease for investigation of primary immunodeficiency facilitates early detection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Murdoch Childrens Research Institute

Other

Collaborators

  • Royal Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 24, 2019
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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