Virulence of Staphylococcus Lugdunensis in Severe Infections (VISLISI)
Primary Purpose
Staphylococcus Lugdunensis, Bacteremia, Endocarditis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Genetic blood sample
Sponsored by
About this trial
This is an interventional basic science trial for Staphylococcus Lugdunensis
Eligibility Criteria
Inclusion Criteria:
- Age 18 or more
- Signed informed consent form
- Proved infection by Staphylococcus lugdunensis: bacteremia, urine tract infection, endocarditis, bone and joint infections, skin and soft tissue infection, deep infection.
Exclusion Criteria:
- Age under 18
- Pregnancy or breastfeeding
- Contamination by Staphylococcus lugdunensis
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with infection by Staphylococcus lugdunensis
Arm Description
Outcomes
Primary Outcome Measures
Presence/absence of virulence factors
Several groups will be compared considering the presence/absence of virulence factors:
Bacteriemic VS non bacteriemic, Deep infection VS Skin/mucosal infection, Foreign body infection VS not, Presence of abscess VS not, Sepsis VS no sepsis, Septic embolism VS not, Portal of entry or not
The following virulence factors will be searched for:
TSST-1, enterotoxins, leukotoxins, epidermolysins, beta-hemolysins, SCIN-CHIPS, Sbi, Efb, SdrE
Secondary Outcome Measures
Clinical characteristics of infections
Characteristics of infection: comorbidities (Charlson score) - history of the disease - clinical, cytological , immunological, inflammatory and organ functions parameters - results of additional tests conducted under their care - response to treatment - morbidity and mortality
Whole human transcriptome analysis for selected patients
Genome sequencing of selected strains of Staphylococcus lugdunensis
Full Information
NCT ID
NCT02026895
First Posted
December 9, 2013
Last Updated
March 4, 2016
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02026895
Brief Title
Virulence of Staphylococcus Lugdunensis in Severe Infections
Acronym
VISLISI
Official Title
Virulence of Staphylococcus Lugdunensis in Severe Infections
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective is to identify new virulence factors produced by Staphylococcus lugdunensis that can be associated with clinical sign of severe infections and identified symptoms. The methodological approach is based on the comparison between the production of toxins by a given S. lugdunensis isolate classified in patients groups according to the infection clinically defined. Each group will be compared to the presence or not of studied virulence factors. Clinical features associated with toxin activity are not known for S. lugdunensis. This comparative approach is based on the hypotheses that drove to the definition of patient groups and their clinical criteria. However, in the absence of the evident correlation between production of toxins and kind of infection, the statistical evaluation will be completed by a multi-varied analysis. This approach has not been choosen first because of the multiple parameters that undergo during infection that may reveal relationships without true correlation. About the number of included patients in each defined group, if one of them does not reach the expected count, we still might extend inclusions to 3-6 months more. The presence of severe infections without usually defined risk is intriguing. For these last patients, we have planned, after their individual consent to achieve an exome sequencing. The obtained data will be compared to available resources for the human genome. By filtering data through usual protocols, we hope to able to focus onto few genes that evoke specific sensitivity to infections, e.g. severe endocarditis due to S. lugdunensis without defined risk.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Lugdunensis, Bacteremia, Endocarditis, Virulence Factors
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with infection by Staphylococcus lugdunensis
Arm Type
Experimental
Intervention Type
Genetic
Intervention Name(s)
Genetic blood sample
Primary Outcome Measure Information:
Title
Presence/absence of virulence factors
Description
Several groups will be compared considering the presence/absence of virulence factors:
Bacteriemic VS non bacteriemic, Deep infection VS Skin/mucosal infection, Foreign body infection VS not, Presence of abscess VS not, Sepsis VS no sepsis, Septic embolism VS not, Portal of entry or not
The following virulence factors will be searched for:
TSST-1, enterotoxins, leukotoxins, epidermolysins, beta-hemolysins, SCIN-CHIPS, Sbi, Efb, SdrE
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary Outcome Measure Information:
Title
Clinical characteristics of infections
Description
Characteristics of infection: comorbidities (Charlson score) - history of the disease - clinical, cytological , immunological, inflammatory and organ functions parameters - results of additional tests conducted under their care - response to treatment - morbidity and mortality
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
Whole human transcriptome analysis for selected patients
Time Frame
Genetic blood samples will be analyzed together after the end of inclusion period (18 months)
Title
Genome sequencing of selected strains of Staphylococcus lugdunensis
Time Frame
Genetic blood samples will be analyzed together after the end of inclusion period (18 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or more
Signed informed consent form
Proved infection by Staphylococcus lugdunensis: bacteremia, urine tract infection, endocarditis, bone and joint infections, skin and soft tissue infection, deep infection.
Exclusion Criteria:
Age under 18
Pregnancy or breastfeeding
Contamination by Staphylococcus lugdunensis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves HANSMANN, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Strasbourg
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
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Virulence of Staphylococcus Lugdunensis in Severe Infections
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