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Clinical Trials/NCT06973174
NCT06973174RecruitingNot Applicable

Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals

Centre Hospitalier Universitaire de Nice13 sites in 1 country40 target enrollmentStarted: January 1, 2010Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
13
Primary Endpoint
Mortality

Study Overview

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.

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Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
— to 143 Days (Child)
Sex
All
Accepts 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

  • Not provided

Outcomes

Primary Outcomes

Mortality

Time Frame: 28 days after birth

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (13)

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