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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03815357
Other study ID # 35266C
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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