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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
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Staphylococcus Lugdunensis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 9, 2013
Last Updated
March 4, 2016
Sponsor
University Hospital, Strasbourg, France
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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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