Invasive Pneumococcal Disease, Recurrent Isolated, 1NCT03815357
What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)?
An observational study of Invasive Pneumococcal Disease, Recurrent Isolated, 1 and Invasive Pneumococcal Disease, Recurrent Isolated, 2, run by Murdoch Childrens Research Institute at 6 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 0 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Invasive Pneumococcal Disease, Recurrent Isolated, 1, Invasive Pneumococcal Disease, Recurrent Isolated, 2, Invasive Pneumococcal Disease, Protection Against
- What is being tested?
- Referral to Immunology
- How many people
- 380 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 31 Jan 2017to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Children aged 0 to 18 years admitted to one of the six centres with IPD.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Australia5 sites
Adelaide Women's and Children's Hospital
Adelaide, South Australia
Lady Cilento Children's Hospital
Brisbane
Monash Health
Clayton, Victoria
Royal Children's Hospital
Melbourne, Victoria, 3049
Sydney Children's Hospital
Sydney, New South Wales, 2031
About this study
Official title: What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)? A Prospective Cohort Study.
This is a multicentre prospective audit to determine the incidence of immunodeficiency in children with IPD.
Aims and/or research question of the project
- To determine the incidence of primary immunodeficiency in children >2 years who present with IPD
- To determine the types of immunodeficiency associated with IPD in children
- Conditions
- Invasive Pneumococcal Disease, Recurrent Isolated, 1, Invasive Pneumococcal Disease, Recurrent Isolated, 2, Invasive Pneumococcal Disease, Protection Against, Primary Immunodeficiency
- Being tested
- Referral to Immunology
- Keywords
- streptococcus pneumoniae, invasive pneumococcal disease, primary immunodeficiency
- Medical subject headings
- IRAK4 Deficiency, Invasive Pneumococcal Disease, Recurrent Isolated, 2, Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral to ImmunologyOther
Screening for primary immunodeficiency including splenic dysfunction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Referral to Immunology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
types of immunodeficiency associated with children who present with invasive pneumococcal disease
This will be determined based on the testing performed by the immunologists.
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start31 Jan 2017
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Invasive Pneumococcal Disease, Recurrent Isolated, 1Studies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815357
- Sponsor's protocol ID
- 35266C
- Status last verified
- Jun 2022
- First submitted
- 12 Dec 2018
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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, 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.
PubMed 24759830Picard 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.
PubMed 14612669Alsina 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.
PubMed 25738983
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)? A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT03815357
- Acronym / sponsor ID
- 35266C
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Royal Children's Hospital
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicentre prospective audit to determine the incidence of immunodeficiency in children with IPD.
Aims and/or research question of the project
- To determine the incidence of primary immunodeficiency in children >2 years who present with IPD
- To determine the types of immunodeficiency associated with IPD in children
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with IPD | – | Other: Referral to ImmunologyChildren 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. |
Who may qualify
- Ages
- 0 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Children aged 0 to 18 years admitted to one of the six centres with IPD.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral to ImmunologyScreening for primary immunodeficiency including splenic dysfunction | Other | Children with IPD |
Primary outcome
incidence of primary immunodeficiency in children who present with invasive pneumococcal disease
Time frame: 3 years
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.
types of immunodeficiency associated with children who present with invasive pneumococcal disease
Time frame: 3 years
This will be determined based on the testing performed by the immunologists.
1 secondary outcome
whether increased referrals of children who present with invasive pneumococcal disease for investigation of primary immunodeficiency facilitates early detection
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Background: PubMed 24759830Gaschignard 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.
- Background: PubMed 14612669Picard 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.
- Background: PubMed 25738983Alsina 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Pneumococcal Disease, Recurrent Isolated, 1 and Invasive Pneumococcal Disease, Recurrent Isolated, 2, run by Murdoch Childrens Research Institute at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of primary immunodeficiency in children who present with invasive pneumococcal disease (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03815357, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.