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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-16
SponsorUniversity Hospital, Montpellier

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
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

Time frame
1 day

Other outcomes

1

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)

Time frame
1 day

Sponsors and contacts

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