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Contamination of Bacillus Species Sepsis. (BACILLUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377530
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier René Dubos

Brief 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.

The purpose of this study is to identify the risk factors of these infections.


Condition or disease Intervention/treatment
Bacillus Cereus Infection Diagnostic Test: Ways to prevent 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.

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Contamination of Bacillus Species Sepsis.
Actual Study Start Date : January 1, 2008
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : August 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
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.
Diagnostic Test: 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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. To collecte the incriminated modes of contamination. [ Time Frame: Through study completion, an average of 1 year. ]
    The purpose of this database is to describe the incriminated modes of contamination.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Newborns infected with Bacillus Species.
Criteria

Inclusion Criteria:

  • cases of Bacillus Species sepsis
  • cases of Bacillus species meningitis
  • with significant change in clinical status
  • Bacillus Species is the only organism isolated

Exclusion Criteria:

  • Bacillus Species isolated with other organisms and Bacillus Species without clinical change were considered to be contaminants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377530


Sponsors and Collaborators
Centre Hospitalier René Dubos
Investigators
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Principal Investigator: Mohamed Amine YANGUI Centre Hospitalier René Dubos
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Responsible Party: Centre Hospitalier René Dubos
ClinicalTrials.gov Identifier: NCT03377530    
Other Study ID Numbers: CHRD1715
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier René Dubos:
Bacillus Cereus
Premature neonates
Additional relevant MeSH terms:
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Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes