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

NCT07111793 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1401

Last updated 2026-04-03

No results posted yet for this study

Summary

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.

Conditions

  • Severe Bacterial Infections

Interventions

OTHER

Extended phenotyping

Extended phenotyping (analysis performed at Nantes University Hospital, MANDATORY DELIVERY WITHIN 24 HOURS) = 1 EDTA 3 mL tube for patients included in Nantes.

OTHER

Blood sample for WES

Blood sample for WES : 1 x 3 mL EDTA tube (if not included in DIABACT IV biocollection)

OTHER

Blood sample for PBMC freezing

Blood sample for PBMC freezing integrated into the biocollection: 1 EDTA tube = 3 mL

OTHER

POPC score evaluation

Assessment of POPC score (Pediatric Overall Performance Category)

OTHER

Questionnaire completion

Questionnaires completed by parents or children: * SDQ * PedSQL4.0

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2027-06-01
Completion
2029-06-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07111793 on ClinicalTrials.gov