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ClinicalTrials.gov ID

NCT06973174

Lead Sponsor

Centre Hospitalier Universitaire de NiceOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

40Estimated

Last Update Posted

Jan 28, 2026Actual

Start Date

Jan 1, 2010Actual

Primary Completion Date

Jul 30, 2026Estimated

Completion Date

Dec 30, 2026Estimated

Official Title

Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals

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.

"

• Sepsis
• Infections

• Premature neonates with invasive infection caused by Bacillus cereus

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Observational Model

Case-Only

Time Perspective

Retrospective

Lead Sponsor

Centre Hospitalier Universitaire de NiceOTHER

Claire.DUPLOYEZ@chu-lille.fr

stephane.corvec@chu-nantes.fr

alix.PANTEL@chu-nimes.fr

asmaa.tazi@aphp.fr

Francois.GUERIN@chu-rennes.fr

dubois.d@chu-toulouse.fr

philippe.lanotte@univ-tours.fr