Bacillus cereus invasive infections in preterm newborns in France
Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals
Researchers will use whole-genome sequencing on bacteria from preterm babies with Bacillus cereus infections to see if certain species or genes are linked to worse outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | N/A to 143 Days |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 13 sites (Nice, Alpes Maritimes and 12 other locations) |
| Trial ID | NCT06973174 on ClinicalTrials.gov |
What this trial studies
This observational project sequences the genomes of Bacillus cereus group strains isolated from invasive infections in preterm neonates hospitalized in France. The team performed whole-genome sequencing on 40 clinical isolates and screened for known virulence genes. Clinical data from the affected neonates were collected and combined with genomic findings to look for factors associated with death or severe disease. The goal is to provide accurate species-level identification and a virulome profile of strains involved in these infections.
Who should consider this trial
Good fit: Preterm newborns (born before 37 weeks) with invasive Bacillus cereus infection confirmed by isolation of the organism from blood or cerebrospinal fluid are the ideal candidates.
Not a fit: Full-term infants, patients without invasive B. cereus infection, or cases where only colonization (not bloodstream/CSF infection) is present are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, the findings could improve identification of dangerous strains, inform infection control, and help guide clinical responses to reduce mortality in preterm infants.
How similar studies have performed: Whole-genome sequencing has been increasingly used in recent reports to classify Bacillus cereus isolates and identify virulence genes, but links between specific species/virulomes and neonatal outcomes remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Premature newborn (i.e born before 37 last menstrual periods) with invasive infection caused by B. cereus (strains isolated from blood culture and cerebrsopinal fluid) Exclusion Criteria: * None
Where this trial is running
Nice, Alpes Maritimes and 12 other locations
- Chu Nice — Nice, Alpes Maritimes, France (Recruiting)
- CHU lille — Lille, France (Recruiting)
- AP-HM Marseille — Marseille, France (Recruiting)
- CHU Nantes — Nantes, France (Recruiting)
- CHU Nîmes — Nîmes, France (Recruiting)
- AP-HP Hôpital Robert Debré — Paris, France (Recruiting)
- Hôpital Antoine Béclère, AP-HP — Paris, France (Recruiting)
- Hôpital Cochin — Paris, France (Recruiting)
- CHU de Poitiers — Poitiers, France (Recruiting)
- CHU Rennes — Rennes, France (Recruiting)
- CHRU de Strasbourg — Strasbourg, France (Recruiting)
- CHU Toulouse — Toulouse, France (Recruiting)
- CHU de Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: Raymond Ruimy
- Email: ruimy.r@chu-nice.fr
- Phone: 04.92.03.62.20
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.