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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
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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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Varies depending on infection occurrence
Samples of bacterial strains are collected from participants for whole genome sequencing.
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
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2
CHU lille
Lille, France
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3
AP-HM Marseille
Marseille, France
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4
CHU Nantes
Nantes, France
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5
CHU Nîmes
Nîmes, France
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6
AP-HP Hôpital Robert Debré
Paris, France
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7
Hôpital Antoine Béclère, AP-HP
Paris, France
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8
Hôpital Cochin
Paris, France
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9
CHU de Poitiers
Poitiers, France
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10
CHU Rennes
Rennes, France
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11
CHRU de Strasbourg
Strasbourg, France
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12
CHU Toulouse
Toulouse, France
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13
CHU de Tours
Tours, France
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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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