Bacillus Cereus InfectionBACILLUSNCT03377530
Contamination of Bacillus Species Sepsis.
An observational study of Bacillus Cereus Infection, run by Hôpital NOVO at 1 site in France.
Trial summary
Bacillus species are ubiquitous gram-positive spore-forming organisms. They rarely cause disease in the immunocompetent and are more frequently isolated as a culture contaminant. However, Bacillus Species can cause severe systemic infections in immunocompromised patients including preterm infants. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Bacillus Cereus Infection
- What is being tested?
- Ways to prevent these infections.
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2008to 31 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 28 days
- All sexes
- Child
Study population: Newborns infected with Bacillus Species.
Who may be able to join
- cases of Bacillus Species sepsis
- cases of Bacillus species meningitis
- with significant change in clinical status
- Bacillus Species is the only organism isolated
Who cannot join
- Bacillus Species isolated with other organisms and Bacillus Species without clinical change were considered to be contaminants
Trial locations and contacts
1 site in 1 country.
About this study
Bacillus species are ubiquitous gram-positive spore-forming organisms. They rarely cause disease in the immunocompetent and are more frequently isolated as a culture contaminant. However, Bacillus Species can cause severe systemic infections in immunocompromised patients including preterm infants.
The purpose of this study is to identify the risk factors of these infections.
Read the detailed description
Non-anthrax Bacillus Species bacteria can be responsible for food poisoning and local infections. Rarely, they lead to severe infections like blood stream infections and meningitis especially in immunocompromised patients like preterm infants.
Bacillus Cereus is the most common members of the genus Bacillus. Only few reports studied these systemic infections in premature neonates. In order to identify the risk factors for severe Bacillus Species infections, we studied retrospectively eleven cases of these infections in our NICU and reviewed series and report cases in literature.
- Conditions
- Bacillus Cereus Infection
- Being tested
- Ways to prevent these infections.
- Keywords
- Bacillus Cereus, Premature neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ways to prevent these infections.Diagnostic test
The purpose of this database is to describe the pathogenicity of this germ, the incriminated modes of contamination.
The collaborators studied the factors of poor prognosis and propose ways to prevent these infections.
| Study group | Role | What they receive |
|---|---|---|
| Premature neonates infected with bacillus Species | The investigators studied retrospectively eleven cases of these infections in our NICU and reviewed series and report cases in literature. Receives: Diagnostic Test: Ways to prevent these infections. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe infection rate due to Bacillus Sp germ
The purpose of this database is to mesure the pathogenicity of this germ based on the severe infection rate
Measured: Through study completion, an average of 1 year.
Secondary outcomes (1)
To collecte the incriminated modes of contamination.
The purpose of this database is to describe the incriminated modes of contamination.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Jan 2008
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacillus Cereus InfectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Amine YANGUI, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377530
- Sponsor's protocol ID
- CHRD1715
- Acronym
- BACILLUS
- Status last verified
- Jun 2026
- First submitted
- 14 Dec 2017
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contamination of Bacillus Species Sepsis.
- ClinicalTrials.gov ID
- NCT03377530
- Acronym / sponsor ID
- BACILLUS / CHRD1715
- Conditions
- Bacillus Cereus Infection
- Keywords
- Bacillus Cereus, Premature neonates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 19 Dec 2017 (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.
Bacillus species are ubiquitous gram-positive spore-forming organisms. They rarely cause disease in the immunocompetent and are more frequently isolated as a culture contaminant. However, Bacillus Species can cause severe systemic infections in immunocompromised patients including preterm infants.
The purpose of this study is to identify the risk factors of these infections.
Detailed description
Non-anthrax Bacillus Species bacteria can be responsible for food poisoning and local infections. Rarely, they lead to severe infections like blood stream infections and meningitis especially in immunocompromised patients like preterm infants.
Bacillus Cereus is the most common members of the genus Bacillus. Only few reports studied these systemic infections in premature neonates. In order to identify the risk factors for severe Bacillus Species infections, we studied retrospectively eleven cases of these infections in our NICU and reviewed series and report cases in literature.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premature neonates infected with bacillus Species | – | Diagnostic Test: Ways to prevent these infections.The investigators studied retrospectively eleven cases of these infections in our NICU and reviewed series and report cases in literature. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- Newborns infected with Bacillus Species.
Key inclusion criteria (4 listed)
- cases of Bacillus Species sepsis
- cases of Bacillus species meningitis
- with significant change in clinical status
- Bacillus Species is the only organism isolated
Key exclusion criteria (1 listed)
- Bacillus Species isolated with other organisms and Bacillus Species without clinical change were considered to be contaminants
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 |
|---|---|---|
| Ways to prevent these infections.The purpose of this database is to describe the pathogenicity of this germ, the incriminated modes of contamination. The collaborators studied the factors of poor prognosis and propose ways to prevent these infections. | Diagnostic test | Premature neonates infected with bacillus Species |
Primary outcome
Severe infection rate due to Bacillus Sp germ
Time frame: Through study completion, an average of 1 year.
The purpose of this database is to mesure the pathogenicity of this germ based on the severe infection rate
1 secondary outcome
To collecte the incriminated modes of contamination.
Time frame: Through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Bacillus Cereus Infection
RecruitingObservational study
Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals
Sepsis, Infections
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. This study is not recruiting at the moment.
Mohamed Amine YANGUI principal investigator
Hôpital NOVO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacillus Cereus Infection, run by Hôpital NOVO at 1 site 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 4 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: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe infection rate due to Bacillus Sp germ (time frame: Through study completion, an average of 1 year.). 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 9 Jun 2026.