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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-06-30

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

Screening for primary immunodeficiency including splenic dysfunction

Interventions

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Referral to Immunology

Screening for primary immunodeficiency including splenic dysfunction

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

0 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Royal Children's Hospital

OTHER

Sponsor Role collaborator

Murdoch Childrens Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sydney Children's Hospital

Sydney, New South Wales, Australia

Site Status

Adelaide Women's and Children's Hospital

Adelaide, South Australia, Australia

Site Status

Monash Health

Clayton, Victoria, Australia

Site Status

Royal Children's Hospital

Melbourne, Victoria, Australia

Site Status

Lady Cilento Children's Hospital

Brisbane, , Australia

Site Status

Capital and Coast District Health Board

Wellington, , New Zealand

Site Status

Countries

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Australia New Zealand

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.

Reference Type BACKGROUND
PMID: 24759830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14612669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25738983 (View on PubMed)

Other Identifiers

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35266C

Identifier Type: -

Identifier Source: org_study_id

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