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

Not yet recruiting

• Conditions: Severe Bacterial Infections

• Registration Number: NCT07111793
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-17
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Study Start: 2025-09-01
• Primary Completion: 2027-04-01
• Study Completion: 2029-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1401

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of innate errors of immunity involved in the development of IBS in pediatrics.	At the enrollment	List of rare genetic variants significantly more frequently found in cases than in controls and/or absent in healthy parents.

Secondary Outcome Measures

Name	Time	Method
Identification of inborn errors of immunity involved in the development of IBS and their association with abnormalities of the immune balance,	At the enrollment
Identification of rare genetic variants favoring certain clinical types of infection, or certain biological and immunological abnormalities.	At the enrollment
Identification of immune deficiencies in patients who have developed a severe bacterial infection	At the enrollment
Assessment of sequelae with the POPC sequelae score (Pediatric Overall Performance Category) at a distance from the IBS episode.	At the enrollment	The POPC sequelae score is a scale from 1 to 6, with 6 being the worst possible outcome.
Assessment of sequelae at a distance from the IBS episode with the Strengths and Weaknesses Questionnaire (SDQ-Fra).	At the enrollment	The SDQ-Fra score is a scale from 0 to 2, with 2 being the worst possible outcome.
Assessment of quality of life at a distance from the IBS episode.	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).

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire Atlantique, France