Contamination of Bacillus Species Sepsis. (BACILLUS)

July 26, 2019 updated by: Centre Hospitalier René Dubos

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

11

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newborns infected with Bacillus Species.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier René Dubos

Investigators

  • Principal Investigator: Mohamed Amine YANGUI, Centre Hospitalier René Dubos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2008

Primary Completion (ACTUAL)

August 31, 2016

Study Completion (ACTUAL)

August 31, 2016

Study Registration Dates

First Submitted

December 14, 2017

First Submitted That Met QC Criteria

December 14, 2017

First Posted (ACTUAL)

December 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 26, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRD1715

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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