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

Severe Infection Clinical Trial

— SPYSI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04990908
• Other study ID #: RECHMPL21_0378
• Status: Recruiting
• Start date: September 4, 2023
• Est. completion date: September 4, 2026

Study information

• Verified date: July 2023
• Source: University Hospital, Montpellier
• Contact: Eric JEZIORSKI
• Phone: 04 67 33 57 98
• Email: e-jeziorski[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 4, 2026
• Est. primary completion date: September 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Immunologic Deficiency Syndromes
• Infections
• Primary Immunodeficiency Diseases
• Severe Infection

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	1 day
Primary	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	1 day
Secondary	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	1 day