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Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals

Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06973174
Enrollment
40
Registered
2025-05-15
Start date
2010-01-01
Completion date
2026-12-30
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Sepsis

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. "

Interventions

BIOLOGICALPremature neonates with invasive infection caused by Bacillus cereus

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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 143 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality28 days after birthThe mortality at D28 after birth was collected in patients record.

Countries

France

Contacts

CONTACTRaymond Ruimy
ruimy.r@chu-nice.fr04.92.03.62.20

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026