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

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ClinicalTrials.gov Identifier: NCT03815357
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Amanda Gwee, 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

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

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children presenting with invasive pneumococcal disease at any of the participating sites listed.

Invasive pneumococcal disease is defined by isolation by culture or PCR of Streptococcus pneumoniae from sterile sites including blood, cerebrospinal fluid (CSF), joint fluid or pleural fluid. In those patients with bacteraemia, their presentation needs to be accompanied by signs of sepsis.

Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Linny K Phuong, MBBS 61(3)93455522 linny.phuong@rch.org.au
Contact: Amanda Gwee, FRACP amanda.gwee@rch.org.au

Locations
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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         
Australia, Victoria
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         
Western Health Recruiting
Melbourne, Victoria, Australia
Contact: David Kreiser         
Principal Investigator: David Kreiser         
Australia
Lady Cilento Children's Hospital Not yet recruiting
Brisbane, Australia
Contact: Julia Clarke         
Sponsors and Collaborators
Murdoch Childrens Research Institute

Publications:
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Responsible Party: Amanda Gwee, Infectious Diseases Consultant, Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT03815357     History of Changes
Other Study ID Numbers: 35266C
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amanda Gwee, Murdoch Childrens Research Institute:
streptococcus pneumoniae
invasive pneumococcal disease
primary immunodeficiency

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Pneumococcal Infections
Immune System Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections