Identification of Clinical, Genetic and Immunological Factors Involved in the Development of Severe Bacterial Infections in Pediatrics (IBSoFACTo)

Nantes University Hospital (NUH)

Status: Not yet enrolling

Conditions: Severe Bacterial Infections

Treatments: Other: POPC score evaluation; Other: Extended phenotyping; Other: Questionnaire completion; Other: Blood sample for WES; Other: Blood sample for PBMC freezing

Study type: Interventional

Funder types: Other

Identifiers

NCT07111793

RC25_0061

2025-A01367-42 (Other Identifier)

Details and patient eligibility

About

Severe bacterial infections (SBI) are responsible for significant morbidity and mortality in the paediatric population. There is considerable individual variability in children's susceptibility to developing SBIs. This variability is multifactorial, and the mechanisms at work are not yet fully understood. The investigators of this study therefore propose to study a population of children who had particularly severe bacterial infections requiring hospitalization in a pediatric intensive care unit in France between 2015 and 2018. This study is part of a global approach to understanding the mechanisms favoring the occurrence of IBS in pediatrics.

The study will initially focus on analyzing the clinical phenotype of these children in terms of the type of infection presented, as well as immunologically with an immune workup of all these patients. The investigators also plan to contact each family individually to identify other episodes of personal or family IBS or other elements suggestive of immune deficiency (opportunistic infections, autoimmune manifestations, severe atopy). The investigators will also assess the persistent sequelae since their infectious episode, and their quality of life following this IBS.

In parallel, the genetic analysis of these patients and their parents will be carried out using whole-exome sequencing. The investigators will compare the results with those obtained in 2 IBS-free control populations (N=70 and N=116). The goal is to identify genetic variants that favor the occurrence of IBS in general, and some that are specific to certain bacteria or clinical presentations.

Enrollment: 1,401 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

For patients:

• Patient included in the DIABACT IV study between 2015 and 2018, following hospitalization in a pediatric intensive care unit in France for a severe bacterial infection.
• Patient affiliated to a social security system
• Patient alive at the time of inclusion.
• Written consent from legal representatives for participation in research. If one of the legal representatives is unable to complete/sign the written consent, it will be sought orally by telephone and recorded in the patient's file. If the patient is over 18, written consent will be obtained. If the patient is a minor, consent will be sought with communication adapted to his/her level of understanding and age.

For parents:

• Patient's biological parents
• Written consent

Exclusion criteria

• Persons under court protection
• Refusal to participate in research

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,401 participants in 2 patient groups

Patients with severe childhood bacterial infections

Other group

Description:

Patient inclus dans l'étude DIABACT IV (NCT02167802) entre 2015 et 2018, dans les suites de son hospitalisation en réanimation pédiatrique en France pour une infection bactérienne sévère.

Treatment:

Other: Blood sample for PBMC freezing

Other: Questionnaire completion

Other: Blood sample for WES

Other: Extended phenotyping

Other: POPC score evaluation

Patient's biological parents

Other group

Treatment:

Other: Questionnaire completion

Other: Blood sample for WES