Clinical trial NCT04990908: Systematic Screening for Primary Immunodeficiencies in Patients Admitted for Severe Infection in Pediatric Intensive Care Unit
Official title: Systematic Screening for Primary Immunodeficiencies in Patients Admitted for Severe Infection in Pediatric Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Infection
Severe Immune Deficiency
Keywords: genetics
screening
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric population

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.


Eligibility criteria: 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.

Primary outcomes:
measure: number of patients with primary immunodeficiency revealed after a severe infection in pediatric ICU or in neuropediatric unit
timeFrame: 1 day
Secondary outcomes:
measure: Rate of to evaluate the sensitivity of our systematic screening
timeFrame: 1 day
Other outcomes:
measure: 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)
timeFrame: 1 day
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Eric JEZIORSKI
role: STUDY_DIRECTOR
References: