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NCT Number: NCT07111793

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital, Nantes, Loire Atlantique, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extended phenotyping

Other

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

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

Blood sample for PBMC freezing

Other

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

POPC score evaluation

Other

Assessment of POPC score (Pediatric Overall Performance Category)

questionnaire completion

Other

Questionnaires completed by parents or children:

  • SDQ
  • PedSQL4.0

Primary outcomes

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

    Time frame: At the enrollment

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

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.

    Time frame: At the enrollment

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

  5. Assessment of sequelae at a distance from the IBS episode with the Strengths and Weaknesses Questionnaire (SDQ-Fra).

    Time frame: At the enrollment

    The SDQ-Fra score is a scale from 0 to 2, with 2 being the worst possible outcome.

  6. Assessment of quality of life at a distance from the IBS episode.

    Time frame: At the enrollment

    Quality of life will be assessed in this patient population using the Pediatric Quality of Life InventoryTM (scale from 0 to 4, with 4 corresponding to the worst outcome).

Study contacts

Contact information is provided by the study sponsor or research team.

Elise LAUNAY

CONTACT

[email protected]

2 40 08 31 79 ext. +33

Sponsor Department

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: IBSoFACTo

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Aug 8, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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