IBSoFACTo : Identification of Clinical, Genetic and Immunological Factors Involved in the Development of Severe Bacterial Infections in Pediatrics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,401
- 试验地点
- 6
- 主要终点
- Identification of innate errors of immunity involved in the development of IBS in pediatrics.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Persons under court protection
- •Refusal to participate in research
研究组 & 干预措施
Patient's biological parents
干预措施: Blood sample for WES (Other)
Patients with severe childhood bacterial infections
Patient inclus dans l'étude DIABACT IV (NCT02167802) entre 2015 et 2018, dans les suites de son hospitalisation en réanimation pédiatrique en France pour une infection bactérienne sévère.
干预措施: Extended phenotyping (Other)
Patient's biological parents
干预措施: Questionnaire completion (Other)
Patients with severe childhood bacterial infections
Patient inclus dans l'étude DIABACT IV (NCT02167802) entre 2015 et 2018, dans les suites de son hospitalisation en réanimation pédiatrique en France pour une infection bactérienne sévère.
干预措施: Blood sample for WES (Other)
Patients with severe childhood bacterial infections
Patient inclus dans l'étude DIABACT IV (NCT02167802) entre 2015 et 2018, dans les suites de son hospitalisation en réanimation pédiatrique en France pour une infection bactérienne sévère.
干预措施: Blood sample for PBMC freezing (Other)
Patients with severe childhood bacterial infections
Patient inclus dans l'étude DIABACT IV (NCT02167802) entre 2015 et 2018, dans les suites de son hospitalisation en réanimation pédiatrique en France pour une infection bactérienne sévère.
干预措施: POPC score evaluation (Other)
Patients with severe childhood bacterial infections
Patient inclus dans l'étude DIABACT IV (NCT02167802) entre 2015 et 2018, dans les suites de son hospitalisation en réanimation pédiatrique en France pour une infection bactérienne sévère.
干预措施: Questionnaire completion (Other)
结局指标
主要结局
Identification of innate errors of immunity involved in the development of IBS in pediatrics.
时间窗: At the enrollment
List of rare genetic variants significantly more frequently found in cases than in controls and/or absent in healthy parents.
次要结局
- 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)
- Assessment of sequelae at a distance from the IBS episode with the Strengths and Weaknesses Questionnaire (SDQ-Fra).(At the enrollment)
- Assessment of quality of life at a distance from the IBS episode.(At the enrollment)
