Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

Up to 143 day

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU NICE, Nice, Alpes Maritimes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Premature neonates with invasive infection caused by Bacillus cereus

Biological

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.

Other names: Bacterial species identification by Whole Genome sequencing

Primary outcomes

Mortality

Time frame: 28 days after birth

The mortality at D28 after birth was collected in patients record.

Study contacts

Contact information is provided by the study sponsor or research team.

Raymond Ruimy

CONTACT

[email protected]

04.92.03.62.20 ext. + 33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2026
Study completion: 2026
First posted: May 15, 2025
Registry last updated: Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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