About this trial
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
This trial does not accept healthy volunteersQualifiers
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
meninges or brain lesions, pleuro-pneumopathy, any infection associated with sepsis and/or an opportunistic germ, septic shock, etc.
Disqualifiers
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;
Trial population
Pediatric population
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
Other outcomes
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)
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)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.