What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)?
NCT ID: NCT03815357
Last Updated: 2022-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
380 participants
OBSERVATIONAL
2017-01-31
2021-06-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Referral to Immunology
Screening for primary immunodeficiency including splenic dysfunction
Interventions
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Referral to Immunology
Screening for primary immunodeficiency including splenic dysfunction
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Children with a known underlying condition predisposing to IPD i.e. nephrotic syndrome.
0 Months
18 Years
ALL
Yes
Sponsors
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Royal Children's Hospital
OTHER
Murdoch Childrens Research Institute
OTHER
Responsible Party
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Locations
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Sydney Children's Hospital
Sydney, New South Wales, Australia
Adelaide Women's and Children's Hospital
Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Royal Children's Hospital
Melbourne, Victoria, Australia
Lady Cilento Children's Hospital
Brisbane, , Australia
Capital and Coast District Health Board
Wellington, , New Zealand
Countries
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References
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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.
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.
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.
Other Identifiers
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35266C
Identifier Type: -
Identifier Source: org_study_id
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