Clinical, genetic, and immune causes of life-threatening bacterial infections in children
IBSoFACTo : Identification of Clinical, Genetic and Immunological Factors Involved in the Development of Severe Bacterial Infections in Pediatrics
This project will use clinical reviews, immune tests, and whole-exome sequencing to see if genetic or immune problems explain why some children who were in pediatric intensive care developed very severe bacterial infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1401 (estimated) |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 6 sites (Nantes, Loire Atlantique and 5 other locations) |
| Trial ID | NCT07111793 on ClinicalTrials.gov |
What this trial studies
The study will re-contact children included in the DIABACT IV cohort who were hospitalized in pediatric intensive care units in France between 2015 and 2018 for severe bacterial infections. Investigators will perform extended clinical phenotyping, immune workups, blood collection for whole-exome sequencing and PBMC biobanking, and collect family history and questionnaire data. Each family will be contacted individually to document other personal or familial episodes suggestive of immune defects. Data will be analyzed to identify clinical, genetic, and immunological factors that may predispose to severe bacterial disease in childhood.
Who should consider this trial
Good fit: Ideal candidates are children from the DIABACT IV cohort who were hospitalized in a French pediatric intensive care unit for a severe bacterial infection between 2015 and 2018, are alive, affiliated with social security, and whose legal representatives can provide consent, along with their biological parents if available.
Not a fit: Patients whose infections are clearly attributable to non-genetic acquired causes or who lack an underlying immune or genetic predisposition, as well as individuals unable or unwilling to consent, are unlikely to receive direct benefit from participation.
Why it matters
Potential benefit: If successful, the project could identify treatable genetic or immune conditions and enable targeted prevention, monitoring, or therapies to reduce future severe infections in affected children.
How similar studies have performed: Previous studies using immune evaluation and whole-exome sequencing have identified inborn errors of immunity in a subset of children with severe bacterial infections, but many cases remain unexplained and this approach is only partially successful.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nantes, Loire Atlantique and 5 other locations
- Nantes University Hospital — Nantes, Loire Atlantique, France (Recruiting)
- CHU de Brest — Brest, France (Not_yet_recruiting)
- Hospices Civils de Lyon — Lyon, France (Not_yet_recruiting)
- Hôpital Armand Trousseau — Paris, France (Not_yet_recruiting)
- Hôpital Necker enfants malades — Paris, France (Not_yet_recruiting)
- CHU de Saint-Étienne — Saint-Etienne, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Elise LAUNAY
- Email: elise.launay@chu-nantes.fr
- Phone: 2 40 08 31 79
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.