Identification of Clinical, Genetic and Immunological Factors Involved in the Development of Severe Bacterial Infections in Pediatrics
NCT ID: NCT07111793
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
1401 participants
INTERVENTIONAL
2026-01-01
2029-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Extended phenotyping
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
Blood sample for WES : 1 x 3 mL EDTA tube (if not included in DIABACT IV biocollection)
Blood sample for PBMC freezing
Blood sample for PBMC freezing integrated into the biocollection: 1 EDTA tube = 3 mL
POPC score evaluation
Assessment of POPC score (Pediatric Overall Performance Category)
Questionnaire completion
Questionnaires completed by parents or children:
* SDQ
* PedSQL4.0
Patient's biological parents
Blood sample for WES
Blood sample for WES : 1 x 3 mL EDTA tube (if not included in DIABACT IV biocollection)
Questionnaire completion
Questionnaires completed by parents or children:
* SDQ
* PedSQL4.0
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Extended phenotyping
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
Blood sample for WES : 1 x 3 mL EDTA tube (if not included in DIABACT IV biocollection)
Blood sample for PBMC freezing
Blood sample for PBMC freezing integrated into the biocollection: 1 EDTA tube = 3 mL
POPC score evaluation
Assessment of POPC score (Pediatric Overall Performance Category)
Questionnaire completion
Questionnaires completed by parents or children:
* SDQ
* PedSQL4.0
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Refusal to participate in research
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Center for Research in Transplantation and Translational Immunology (UMR_S 1064)
UNKNOWN
Nantes University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nantes University Hospital
Nantes, Loire Atlantique, France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-A01367-42
Identifier Type: OTHER
Identifier Source: secondary_id
RC25_0061
Identifier Type: -
Identifier Source: org_study_id