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

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Infection; Severe Immune Deficiency

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Eric JEZIORSKI; Phone Number: 33 04 67 33 57 98; Email: e-jeziorski@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Uhmontpellier
    • Contact: Eric Jeziorski, MCU-PH; Phone Number: 33 04 67 33 66 03; Email: e-jeziorski@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 16 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric population

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Eric JEZIORSKI, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Estimated): September 4, 2025
• Study Completion (Estimated): September 4, 2026

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: genetics; screening
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Disease Attributes; Genetic Diseases, Inborn; Infections; Communicable Diseases; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases
• Other Study ID Numbers: RECHMPL21_0378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No