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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03815357




Registration number
NCT03815357
Ethics application status
Date submitted
12/12/2018
Date registered
24/01/2019
Date last updated
24/01/2019

Titles & IDs
Public title
What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)?
Scientific title
What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)? A Prospective Cohort Study.
Secondary ID [1] 0 0
35266C
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Invasive Pneumococcal Disease, Recurrent Isolated, 1 0 0
Invasive Pneumococcal Disease, Recurrent Isolated, 2 0 0
Invasive Pneumococcal Disease, Protection Against 0 0
Primary Immunodeficiency 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Referral to Immunology

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 interventions: Referral to Immunology
Screening for primary immunodeficiency and splenic dysfunction

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
3 years
Primary outcome [2] 0 0
types of immunodeficiency associated with children who present with invasive pneumococcal disease - This will be determined based on the testing performed by the immunologists.
Timepoint [2] 0 0
3 years
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
3 years

Eligibility
Key inclusion criteria
- Children aged 0 to 18 years admitted to one of the six centres with IPD.
Minimum age
No limit
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Royal Hospital for Women - Sydney
Recruitment hospital [2] 0 0
Adelaide Women's and Children's Hospital - Adelaide
Recruitment hospital [3] 0 0
Royal Children's Hospital - Melbourne
Recruitment hospital [4] 0 0
Western Health - Melbourne
Recruitment hospital [5] 0 0
Lady Cilento Children's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
3049 - Melbourne
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
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. 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
Trial website
https://clinicaltrials.gov/show/NCT03815357
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Linny K Phuong, MBBS
Address 0 0
Country 0 0
Phone 0 0
61(3)93455522
Fax 0 0
Email 0 0
linny.phuong@rch.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03815357