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

Study acronym: IBSoFACTo
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Jun 1, 2027 → Dec 18, 2027
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Record History

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  1. Notable Primary completion pushed from Jun 1, 2027 to Dec 18, 2027
    • Study completion pushed from Jun 1, 2029 to Dec 18, 2029
    • Study sites: 6 to 7
    • Eligibility criteria expanded, about 8 words
  2. Notable Recruitment opened
    • Start date changed from estimate of Jan 1, 2026 to Mar 18, 2026
    • Site details revised at 6 of 6 sites
    v4
  3. Minor Study sites: 1 to 6
    • Collaborators shortened, about 10 words
    v3
  4. Notable Phase: Not specified to Not applicable
    • Start date: Sep 1, 2025 to Jan 1, 2026
    • Primary completion date: Apr 1, 2027 to Jun 1, 2027
    • Study completion date: Apr 1, 2029 to Jun 1, 2029
    v2
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07111793
Lead Sponsor Nantes University Hospital
Conditions
(from sponsor)
Severe Bacterial Infections
Related terms Bacterial Infections
Enrollment 1,401 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov