What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03815357|
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
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
|Condition or disease||Intervention/treatment|
|Invasive Pneumococcal Disease, Recurrent Isolated, 1 Invasive Pneumococcal Disease, Recurrent Isolated, 2 Invasive Pneumococcal Disease, Protection Against Primary Immunodeficiency||Other: Referral to Immunology|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)? A Prospective Cohort Study.|
|Actual Study Start Date :||January 31, 2017|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2020|
Children with IPD
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
Screening for primary immunodeficiency and splenic dysfunction
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815357
|Contact: Linny K Phuong, MBBS||61(3)email@example.com|
|Contact: Amanda Gwee, FRACPfirstname.lastname@example.org|
|Australia, New South Wales|
|Royal Hospital for Women||Not yet recruiting|
|Sydney, New South Wales, Australia, 2031|
|Contact: Brendan McMullan|
|Sub-Investigator: Prai Sinnappurajar|
|Principal Investigator: Brendan McMullan|
|Sub-Investigator: Catherine Frith|
|Australia, South Australia|
|Adelaide Women's and Children's Hospital||Recruiting|
|Adelaide, South Australia, Australia|
|Contact: Abigail Cheung|
|Contact: Rishi Agarwal|
|Principal Investigator: Abigail Cheung|
|Sub-Investigator: Rishi Agarwal|
|Sub-Investigator: Patrick Quinn|
|Royal Children's Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3049|
|Contact: Amanda Gwee, FRACP|
|Principal Investigator: Linny K Phuong, MBBS|
|Sub-Investigator: Amanda Gwee, FRACP|
|Sub-Investigator: Theresa Cole|
|Melbourne, Victoria, Australia|
|Contact: David Kreiser|
|Principal Investigator: David Kreiser|
|Lady Cilento Children's Hospital||Not yet recruiting|
|Contact: Julia Clarke|