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

NCT03815357 | Completed

• 1 other identifier: 35266C
• Study Type: observational
• Target: 380
• Locations: 2 countries
• Sites: 6

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

Conditions

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

Keywords

streptococcus pneumoniae; invasive pneumococcal disease; primary immunodeficiency

Outcome Measures

Primary Outcomes (2)

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

  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.

  3 years

• types of immunodeficiency associated with children who present with invasive pneumococcal disease

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

  3 years

Secondary Outcomes (1)

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

  3 years

Study Arms (1)

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

Interventions

Referral to Immunology OTHER

Screening for primary immunodeficiency including splenic dysfunction

Children with IPD

Eligibility Criteria

• Age: 0 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Children aged 0 to 18 years admitted to one of the six centres with IPD.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Royal Children's Hospital: collaborator

Study Sites (6)

Sydney Children's Hospital

Sydney, New South Wales, 2031, Australia

Location

Adelaide Women's and Children's Hospital

Adelaide, South Australia, Australia

Location

Monash Health

Clayton, Victoria, Australia

Location

Royal Children's Hospital

Melbourne, Victoria, 3049, Australia

Location

Lady Cilento Children's Hospital

Brisbane, Australia

Location

Capital and Coast District Health Board

Wellington, New Zealand

Location

Related Publications (3)

• Gaschignard J, Levy C, Chrabieh M, Boisson B, Bost-Bru C, Dauger S, Dubos F, Durand P, Gaudelus J, Gendrel D, Gras Le Guen C, Grimprel E, Guyon G, Jeudy C, Jeziorski E, Leclerc F, Leger PL, Lesage F, Lorrot M, Pellier I, Pinquier D, de Pontual L, Sachs P, Thomas C, Tissieres P, Valla FV, Desprez P, Fremeaux-Bacchi V, Varon E, Bossuyt X, Cohen R, Abel L, Casanova JL, Puel A, Picard C. Invasive pneumococcal disease in children can reveal a primary immunodeficiency. Clin Infect Dis. 2014 Jul 15;59(2):244-51. doi: 10.1093/cid/ciu274. Epub 2014 Apr 23.

  PMID: 24759830 BACKGROUND

• Picard C, Puel A, Bustamante J, Ku CL, Casanova JL. Primary immunodeficiencies associated with pneumococcal disease. Curr Opin Allergy Clin Immunol. 2003 Dec;3(6):451-9. doi: 10.1097/00130832-200312000-00006.

  PMID: 14612669 BACKGROUND

• Alsina L, Basteiro MG, de Paz HD, Inigo M, de Sevilla MF, Trivino M, Juan M, Munoz-Almagro C. Recurrent invasive pneumococcal disease in children: underlying clinical conditions, and immunological and microbiological characteristics. PLoS One. 2015 Mar 4;10(3):e0118848. doi: 10.1371/journal.pone.0118848. eCollection 2015.

  PMID: 25738983 BACKGROUND

MeSH Terms

Conditions

IRAK4 Deficiency; Invasive Pneumococcal Disease, Recurrent Isolated, 2; Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: January 24, 2019
• Study Start: January 31, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); NZ (1)