Actively Recruiting

Age: 0 - 143Days
All Genders
ID06973174

Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals

Led by Centre Hospitalier Universitaire de Nice · Updated on 2026-01-28

40

Participants Needed

13

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying invasive infections caused by Bacillus cereus group bacteria in premature newborns hospitalized in French hospitals. These infections have recently been linked to serious conditions like sepsis and septic shock in preterm neonates, with mortality rates up to 30%. The study aims to identify the specific bacterial species involved and analyze their virulence genes to understand factors linked to poor outcomes. The study uses whole genome sequencing with advanced Illumina and Nanopore technologies to examine bacterial strains isolated from blood and cerebrospinal fluid of affected premature newborns. This observational research focuses on accurately characterizing the bacteria causing infections and their genetic profiles. Participants are premature newborns born before 37 weeks who have invasive infections caused by Bacillus cereus. The study collects clinical data and bacterial genomic information to analyze risk factors for death, with mortality measured up to 28 days after birth. The study is sponsored by Centre Hospitalier Universitaire de Nice and runs through December 2026.

CONDITIONS

Brief Title

Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals

Who Can Participate

Age: 0 - 143Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Premature newborn (born before 37 last menstrual periods) with invasive infection caused by B. cereus
  • B. cereus strains isolated from blood culture or cerebrospinal fluid
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Sample Collection

Duration - Varies depending on infection occurrence

Samples of bacterial strains are collected from participants for whole genome sequencing.

Long-term Monitoring

Duration - Up to 28 days after birth

Participants are monitored for health outcomes including mortality up to 28 days after birth.

Trial Site Locations

Total: 13 locations

1

CHU NICE

Nice, Alpes Maritimes, France, 06000

Actively Recruiting

2

CHU lille

Lille, France

Actively Recruiting

3

AP-HM Marseille

Marseille, France

Actively Recruiting

4

CHU Nantes

Nantes, France

Actively Recruiting

5

CHU Nîmes

Nîmes, France

Actively Recruiting

6

AP-HP Hôpital Robert Debré

Paris, France

Actively Recruiting

7

Hôpital Antoine Béclère, AP-HP

Paris, France

Actively Recruiting

8

Hôpital Cochin

Paris, France

Actively Recruiting

9

CHU de Poitiers

Poitiers, France

Actively Recruiting

10

CHU Rennes

Rennes, France

Actively Recruiting

11

CHRU de Strasbourg

Strasbourg, France

Actively Recruiting

12

CHU Toulouse

Toulouse, France

Actively Recruiting

13

CHU de Tours

Tours, France

Actively Recruiting

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Research Team

R

Raymond Ruimy

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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