Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals
1 other identifier
observational
40
1 country
13
Brief Summary
Background. Bacillus cereus group (Bc) comprises twenty-six closely related species of spore-forming environmental bacteria. Recently, increased sepsis and septic shock caused by Bc were reported in preterm neonates (PN), and the mortality rate can reach up to 30%. Using Whole Genome Sequencing (WGS) increasingly used to characterize Bc strains, The team aimed to determine an accurate identification to the species level of the strains involved in Bc invasive infections in preterm neonates in France and study their virulome profile.Methods. The team performed WGS for 40 neonate clinical strains responsible for invasive infections in PN. A screening of virulence genes was performed to characterize strains associated with poor prognosis. Clinical data were collected and all clinical and genomic findings were analyzed for risk factors for death. "
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2010
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 5, 2025
CompletedFirst Posted
Study publicly available on registry
May 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
January 28, 2026
January 1, 2026
16.6 years
May 5, 2025
January 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality
The mortality at D28 after birth was collected in patients record.
28 days after birth
Interventions
The whole genome sequencing of the bacterial strains was performed by using both Illumina and Nanopore technologies, allowing us to obatin high quality and complete circular genomes.
Eligibility Criteria
The premature newborn included in the study were recruited from 14 NICU in 14 Tertiary Care center in France. This study is a national retrospective study
You may qualify if:
- 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)
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
CHU NICE
Nice, Alpes Maritimes, 06000, France
CHU lille
Lille, France
AP-HM Marseille
Marseille, France
CHU Nantes
Nantes, France
CHU Nîmes
Nîmes, France
AP-HP Hôpital Robert Debré
Paris, France
Hôpital Antoine Béclère, AP-HP
Paris, France
Hôpital Cochin
Paris, France
CHU de Poitiers
Poitiers, France
CHU Rennes
Rennes, France
CHRU de Strasbourg
Strasbourg, France
CHU Toulouse
Toulouse, France
CHU de Tours
Tours, France
Biospecimen
Only the bacteial strains (isolated from patients blood culture samples were retained. Only bacterial DNA was extractable from these samples and not patient DNA.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2025
First Posted
May 15, 2025
Study Start
January 1, 2010
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
January 28, 2026
Record last verified: 2026-01