Severe InfectionSPYSINCT04990908
Systematic Screening for Primary Immunodeficiencies in Patients Admitted for Severe Infection in Pediatric Intensive Care Unit
An observational study of Severe Infection and Severe Immune Deficiency, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Severe infections in pediatric intensive care unit are not uncommon. Historically, the diagnosis of hereditary (primary) immune deficiency required a combination of recurrent clinical signs and biological stigmas. Read more about this study
- Who is it for?
- Ages 3 months to 16 years
- Conditions the study is for
- Severe Infection, Severe Immune Deficiency
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2023to 4 Sep 2026
- 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 3 months to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric population
Who may be able to join
- Inclusion age > 3 months of actual age for term infants and > 3 months for former preterm infants.
- Documented severe infection (bacterial, viral, fungal) at the University Hospital Center of Montpellier, Toulouse or Marseille
- Severe infections concerned by the study: any infection requiring hospitalization in pediatric intensive care (more than 24 hours) including:
- meninges or brain lesions, pleuro-pneumopathy, any infection associated with sepsis and/or an opportunistic germ, septic shock, etc.
- Encephalitis and encephalomyelitis of infectious origin
- Child benefiting from a social security system
- Collection of parental/legal representative consent
Who cannot join
- Undocumented severe infections
- Acute bronchiolitis
- Children admitted with isolated SRV bronchiolitis without further complications from the infection;
- Previous comorbidity explaining the infection and/or stay in ICU/Continuing Care: Primary or known secondary immune deficiency; burns; risk factors for non-infectious epilepsy (encephalopathy, known epilepsy, head trauma), pneumonia caused by swallowing disorders or tracheotomy or chronic lung disease, asthma, meningitis favored by cochlear implants, breach of blood-brain barrier or neuromeningetic material, deep infection on implanted material or within 48h after surgery, cardiovascular decompensation; any other chronic conditions that may contribute to infection;
- Inability to obtain consent from parents/legal guardians.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Eric Jeziorski, MCU-PH, 04 67 33 66 03 ext. 33, e-jeziorski@chu-montpellier.fr
About this study
Severe infections in pediatric intensive care unit are not uncommon. Historically, the diagnosis of hereditary (primary) immune deficiency required a combination of recurrent clinical signs and biological stigmas. This paradigm is currently being questioned, and grows the hypothesis of a potential underlying genetic susceptibility in any severe infection. To date, the proportion of severe infections explained by an underlying immune deficiency is unknown.
The aim of this prospective study is to assess the incidence of primary immune deficiencies in children with severe infection, regardless of their etiology.
- Conditions
- Severe Infection, Severe Immune Deficiency
- Keywords
- genetics, screening
- Medical subject headings
- Infections, Immunologic Deficiency Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with primary immunodeficiency revealed after a severe infection in pediatric ICU or in neuropediatric unit
number of patients with primary immunodeficiency revealed after a severe infection in pediatric ICU or in neuropediatric unit
Measured: 1 day
Secondary outcomes (1)
Rate of to evaluate the sensitivity of our systematic screening
To evaluate the sensitivity of our systematic screening in relation to an approach scrupulously following the indications of other published studies for the screening of primary immunodeficiencies
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start4 Sep 2023
- Primary completion4 Sep 2025 (estimated)
- Study completion4 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe InfectionStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric JEZIORSKI, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990908
- Sponsor's protocol ID
- RECHMPL21_0378
- Acronym
- SPYSI
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2021
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Screening for Primary Immunodeficiencies in Patients Admitted for Severe Infection in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04990908
- Acronym / sponsor ID
- SPYSI / RECHMPL21_0378
- Conditions
- Severe Infection, Severe Immune Deficiency
- Keywords
- genetics, screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 4 Sep 2025 (estimated)
- Study completion
- 4 Sep 2026 (estimated)
- First posted
- 5 Aug 2021 (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.
Severe infections in pediatric intensive care unit are not uncommon. Historically, the diagnosis of hereditary (primary) immune deficiency required a combination of recurrent clinical signs and biological stigmas. This paradigm is currently being questioned, and grows the hypothesis of a potential underlying genetic susceptibility in any severe infection. To date, the proportion of severe infections explained by an underlying immune deficiency is unknown.
The aim of this prospective study is to assess the incidence of primary immune deficiencies in children with severe infection, regardless of their etiology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric population
Key inclusion criteria (7 listed)
- Inclusion age > 3 months of actual age for term infants and > 3 months for former preterm infants.
- Documented severe infection (bacterial, viral, fungal) at the University Hospital Center of Montpellier, Toulouse or Marseille
- Severe infections concerned by the study: any infection requiring hospitalization in pediatric intensive care (more than 24 hours) including:
- meninges or brain lesions, pleuro-pneumopathy, any infection associated with sepsis and/or an opportunistic germ, septic shock, etc.
- Encephalitis and encephalomyelitis of infectious origin
Key exclusion criteria (5 listed)
- Undocumented severe infections
- Acute bronchiolitis
- Children admitted with isolated SRV bronchiolitis without further complications from the infection;
- Previous comorbidity explaining the infection and/or stay in ICU/Continuing Care: Primary or known secondary immune deficiency; burns; risk factors for non-infectious epilepsy (encephalopathy, known epilepsy, head trauma), pneumonia caused by swallowing disorders or tracheotomy or chronic lung disease, asthma, meningitis favored by cochlear implants, breach of blood-brain barrier or neuromeningetic material, deep infection on implanted material or within 48h after surgery, cardiovascular decompensation; any other chronic conditions that may contribute to infection;
- Inability to obtain consent from parents/legal guardians.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of patients with primary immunodeficiency revealed after a severe infection in pediatric ICU or in neuropediatric unit
Time frame: 1 day
number of patients with primary immunodeficiency revealed after a severe infection in pediatric ICU or in neuropediatric unit
1 secondary outcome
Rate of to evaluate the sensitivity of our systematic screening
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: Undecided. NC
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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.
Eric JEZIORSKI study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Infection and Severe Immune Deficiency, run by University Hospital, Montpellier at 1 site in France.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric JEZIORSKI (04 67 33 57 98 ext. 33, e-jeziorski@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with primary immunodeficiency revealed after a severe infection in pediatric ICU or in neuropediatric unit (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2024.