Clinical trial NCT03815357: What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)?
Official title: What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)? A Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Pneumococcal Disease, Recurrent Isolated, 1
Invasive Pneumococcal Disease, Recurrent Isolated, 2
Invasive Pneumococcal Disease, Protection Against
Primary Immunodeficiency
Keywords: streptococcus pneumoniae
invasive pneumococcal disease
primary immunodeficiency
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: Royal Children's Hospital
First posted: 2019-01-24
Enrollment: 380
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children presenting with invasive pneumococcal disease at any of the participating sites listed.

Invasive pneumococcal disease is defined by isolation by culture or PCR of Streptococcus pneumoniae from sterile sites including blood, cerebrospinal fluid (CSF), joint fluid or pleural fluid. In those patients with bacteraemia, their presentation needs to be accompanied by signs of sepsis.

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


Eligibility criteria: 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.

Primary outcomes:
measure: incidence of primary immunodeficiency in children who present with invasive pneumococcal disease
timeFrame: 3 years
measure: types of immunodeficiency associated with children who present with invasive pneumococcal disease
timeFrame: 3 years
Secondary outcomes:
measure: whether increased referrals of children who present with invasive pneumococcal disease for investigation of primary immunodeficiency facilitates early detection
timeFrame: 3 years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Adelaide Women's and Children's Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Melbourne
country: Australia
facility: Royal Children's Hospital
state: Victoria
city: Brisbane
country: Australia
facility: Lady Cilento Children's Hospital
city: Wellington
country: New Zealand
facility: Capital and Coast District Health Board
Study officials:
References:
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, 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.
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. doi: 10.1097/00130832-200312000-00006.
citation: 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.