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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

Tracking Information
First Submitted Date December 14, 2017
First Posted Date December 19, 2017
Last Update Posted Date July 30, 2019
Actual Study Start Date January 1, 2008
Actual Primary Completion Date August 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 26, 2019)
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
Original Primary Outcome Measures
 (submitted: December 14, 2017)
Pathogenicity of this germ [ Time Frame: Through study completion, an average of 1 year. ]
The purpose of this database is to describe the pathogenicity of this germ.
Change History
Current Secondary Outcome Measures
 (submitted: July 26, 2019)
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.
Original Secondary Outcome Measures
 (submitted: December 14, 2017)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Contamination of Bacillus Species Sepsis.
Official Title Contamination of Bacillus Species Sepsis.
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Newborns infected with Bacillus Species.
Condition Bacillus Cereus Infection
Intervention 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.

Study Groups/Cohorts 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.
Intervention: Diagnostic Test: Ways to prevent these infections.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 14, 2017)
11
Original Actual Enrollment Same as current
Actual Study Completion Date August 31, 2016
Actual Primary Completion Date August 31, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 28 Days   (Child)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03377530
Other Study ID Numbers CHRD1715
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier René Dubos
Study Sponsor Centre Hospitalier René Dubos
Collaborators Not Provided
Investigators
Principal Investigator: Mohamed Amine YANGUI Centre Hospitalier René Dubos
PRS Account Centre Hospitalier René Dubos
Verification Date July 2019