SepsisNCT06973174
Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals
An observational study of Sepsis and Infections, run by Centre Hospitalier Universitaire de Nice at 13 sites in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages Up to 143 days
- Conditions the study is for
- Sepsis, Infections
- What is being tested?
- Premature neonates with invasive infection caused by Bacillus cereus
- How many people
- 40 participants
- Where
- 13 sitesFrance
- Study dates
- 1 Jan 2010to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 143 days
- All sexes
- No healthy volunteers
- Child
Study population: The premature newborn included in the study were recruited from 14 NICU in 14 Tertiary Care center in France. This study is a national retrospective study
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 13 recruiting
- Recruiting
CHU lille
Lille
Claire Duployez, Claire.DUPLOYEZ@chu-lille.fr
- Recruiting
AP-HM Marseille
Marseille
Gregory Dubourg, gregory.DUBOURG@univ-amu.fr
- Recruiting
CHU Nantes
Nantes
Stéphane Corvec, stephane.corvec@chu-nantes.fr
- Recruiting
CHU NICE
Nice, Alpes Maritimes, 06000
Raymond Ruimy, 0492036220, ruimy.r@chu-nice.fr
Carole, 0667336090, charavet.c@chu-nice.fr
- Recruiting
CHU Nîmes
Nîmes
Alix Pantel, alix.PANTEL@chu-nimes.fr
- Recruiting
AP-HP Hôpital Robert Debré
Paris
André Birgy, andre.birgy@aphp.fr
- Recruiting
Hôpital Antoine Béclère, AP-HP
Paris
Nadege Bourgeois Nicolaos, nadege.bourgeois@aphp.fr
- Recruiting
Hôpital Cochin
Paris
Asmaa Tazi, asmaa.tazi@aphp.fr
- Recruiting
CHU de Poitiers
Poitiers
Maxime PICHON, maxime.pichon@chu-poitiers.fr
- Recruiting
CHU Rennes
Rennes
Francois Guerin, Francois.GUERIN@chu-rennes.fr
- Recruiting
CHRU de Strasbourg
Strasbourg
Pierre Boyer, pierre.boyer-ext@aphp.fr
- Recruiting
CHU Toulouse
Toulouse
Damien Dubois, dubois.d@chu-toulouse.fr
- Recruiting
CHU de Tours
Tours
Philippe Lanotte, philippe.lanotte@univ-tours.fr
About this study
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.
"
- Conditions
- Sepsis, Infections
- Being tested
- Premature neonates with invasive infection caused by Bacillus cereus
- Medical subject headings
- Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premature neonates with invasive infection caused by Bacillus cereusBiological
Also called Bacterial species identification by Whole Genome sequencing
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The mortality at D28 after birth was collected in patients record.
Measured: 28 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Jan 2010
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973174
- Sponsor's protocol ID
- 25LaboBacterio01
- Status last verified
- Jan 2026
- First submitted
- 5 May 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals
- ClinicalTrials.gov ID
- NCT06973174
- Acronym / sponsor ID
- 25LaboBacterio01
- Conditions
- Sepsis, Infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
"
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 143 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The premature newborn included in the study were recruited from 14 NICU in 14 Tertiary Care center in France. This study is a national retrospective study
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Premature neonates with invasive infection caused by Bacillus cereusAlso: Bacterial species identification by Whole Genome sequencingThe 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. | Biological | – |
Primary outcome
Mortality
Time frame: 28 days after birth
The mortality at D28 after birth was collected in patients record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Infections, run by Centre Hospitalier Universitaire de Nice at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raymond Ruimy (04.92.03.62.20 ext. + 33, ruimy.r@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 days after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.