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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01367-42 | Other Identifier | ANSM - IDRCB |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with severe childhood bacterial infections | Other | 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. |
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| Patient's biological parents | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
For patients:
For parents:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elise LAUNAY | Contact | 2 40 08 31 79 | +33 | elise.launay@chu-nantes.fr |
| Sponsor Department | Contact | bp-prom-regl@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Recruiting | Nantes | Loire Atlantique | 44093 | France |
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| Blood sample for WES | Other | Blood sample for WES : 1 x 3 mL EDTA tube (if not included in DIABACT IV biocollection) |
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| Blood sample for PBMC freezing | Other | Blood sample for PBMC freezing integrated into the biocollection: 1 EDTA tube = 3 mL |
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| POPC score evaluation | Other | Assessment of POPC score (Pediatric Overall Performance Category) |
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| Questionnaire completion | Other | Questionnaires completed by parents or children:
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| 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. | The POPC sequelae score is a scale from 1 to 6, with 6 being the worst possible outcome. | At the enrollment |
| Assessment of sequelae at a distance from the IBS episode with the Strengths and Weaknesses Questionnaire (SDQ-Fra). | The SDQ-Fra score is a scale from 0 to 2, with 2 being the worst possible outcome. | At the enrollment |
| Assessment of quality of life at a distance from the IBS episode. | 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). | At the enrollment |
| CHU de Brest | Not yet recruiting | Brest | France |
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| Hospices Civils de Lyon | Not yet recruiting | Lyon | France |
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| Hôpital Armand Trousseau | Not yet recruiting | Paris | France |
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| Hôpital Necker enfants malades | Not yet recruiting | Paris | France |
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| CHU de Saint-Étienne | Not yet recruiting | Saint-Etienne | France |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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