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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Persons under court protection

Refusal to participate in research

Trial design

Design model

Parallel

Treatments tested in this trial

  • Extended phenotyping

    Other intervention

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

  • Blood sample for WES

    Other intervention

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

  • Blood sample for PBMC freezing

    Other intervention

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

  • POPC score evaluation

    Other intervention

    Assessment of POPC score (Pediatric Overall Performance Category)

  • Questionnaire completion

    Other intervention

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

Treatment groups

1,401 Participants
are divided into 2 treatment groups
Group A: Patients with severe childhood bacterial infectionsOther 5 interventions
Group B: Patient's biological parentsOther 2 interventions

Trial outcomes

Primary outcomes

1

Identification of innate errors of immunity involved in the development of IBS in pediatrics.

List of rare genetic variants significantly more frequently found in cases than in controls and/or absent in healthy parents.

Time frame
At the enrollment

Secondary outcomes

1

Identification of inborn errors of immunity involved in the development of IBS and their association with abnormalities of the immune balance,

Time frame
At the enrollment
2

Identification of rare genetic variants favoring certain clinical types of infection, or certain biological and immunological abnormalities.

Time frame
At the enrollment
3

Identification of immune deficiencies in patients who have developed a severe bacterial infection

Time frame
At the enrollment
4

Assessment of sequelae with the POPC sequelae score (Pediatric Overall Performance Category) at a distance from the IBS episode.

The POPC sequelae score is a scale from 1 to 6, with 6 being the worst possible outcome.

Time frame
At the enrollment

Other outcomes

Sponsors and contacts

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