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

Primary Immunodeficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03815357
• Other study ID #: 35266C
• Status: Completed
• Start date: January 31, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2022
• Source: Murdoch Childrens Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune System Diseases
• Immunologic Deficiency Syndromes
• Invasive Pneumococcal Disease, Protection Against
• Invasive Pneumococcal Disease, Recurrent Isolated, 1
• Invasive Pneumococcal Disease, Recurrent Isolated, 2
• Pneumococcal Infections
• Primary Immunodeficiency
• Primary Immunodeficiency Diseases
• Recurrence

Intervention

Other:
• Referral to Immunology
Screening for primary immunodeficiency including splenic dysfunction

Locations

Country	Name	City	State
Australia	Adelaide Women's and Children's Hospital	Adelaide	South Australia
Australia	Lady Cilento Children's Hospital	Brisbane
Australia	Monash Health	Clayton	Victoria
Australia	Royal Children's Hospital	Melbourne	Victoria
Australia	Sydney Children's Hospital	Sydney	New South Wales
New Zealand	Capital and Coast District Health Board	Wellington

Sponsors (2)

Lead Sponsor	Collaborator
Murdoch Childrens Research Institute	Royal Children's Hospital

Countries where clinical trial is conducted

Australia,  New Zealand, 

References & Publications (3)

Alsina L, Basteiro MG, de Paz HD, Iñigo M, de Sevilla MF, Triviño M, Juan M, Muñoz-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. — View Citation

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, Léger PL, Lesage F, Lorrot M, Pellier I, Pinquier D, de Pontual L, Sachs P, Thomas C, Tissières P, Valla FV, Desprez P, Frémeaux-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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	whether increased referrals of children who present with invasive pneumococcal disease for investigation of primary immunodeficiency facilitates early detection	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.	3 years