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NCT07111793: IBSoFACTo
Identification of Clinical, Genetic and Immunological Factors Involved in the Development of Severe Bacterial Infections in Pediatrics
NA trial testing Extended phenotyping in Severe Bacterial Infections in 1,401 participants. Currently enrolling.
1 June 2027
Quick facts
| Lead sponsor | Nantes University Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 1,401 |
| Start date | 18 March 2026 |
| Primary completion | 1 June 2027 |
| Estimated completion | 1 June 2029 |
| Sites | 6 locations across France |
Drugs / interventions tested
- Extended phenotyping
- Blood sample for WES
- Blood sample for PBMC freezing
- POPC score evaluation
- Questionnaire completion
Conditions studied
- Severe Bacterial Infections — all drugs for Severe Bacterial Infections →
Sponsor
Nantes University Hospital
Who can join
Eligibility, any sex, with Severe Bacterial Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07111793
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07111793 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nantes University Hospital
- Last refreshed: 3 April 2026
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