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Systematic Screening for Primary Immunodeficiencies in Patients Admitted for Severe Infection in Pediatric Intensive Care Unit

Systematic Screening for Primary Immunodeficiencies in Patients Admitted for Severe Infection in Pediatric Intensive Care Unit

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04990908
Acronym
SPYSI
Enrollment
100
Registered
2021-08-05
Start date
2023-09-04
Completion date
2026-09-04
Last updated
2024-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Immune Deficiency, Severe Infection

Keywords

genetics, screening

Brief 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. 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.

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 16 Years
Healthy volunteers
No

Inclusion criteria

* Inclusion age less than 16 years * 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
number of patients with primary immunodeficiency revealed after a severe infection in pediatric ICU or in neuropediatric unit1 daynumber of patients with primary immunodeficiency revealed after a severe infection in pediatric ICU or in neuropediatric unit

Secondary

MeasureTime frameDescription
Rate of to evaluate the sensitivity of our systematic screening1 dayTo 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

Other

MeasureTime frameDescription
The number of immune deficiencies that have no other call point based on the list of warning signs of the Reference Center for Hereditary Immune Deficiencies (CEREDIH)1 dayThe number of immune deficiencies that have no other call point based on the list of warning signs of the Reference Center for Hereditary Immune Deficiencies (CEREDIH)

Countries

France

Contacts

Primary ContactEric JEZIORSKI
e-jeziorski@chu-montpellier.fr04 67 33 57 98

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026