Virulence of Staphylococcus Lugdunensis in Severe Infections (VISLISI)

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. Identifier: NCT02026895
Recruitment Status : Completed
First Posted : January 3, 2014
Last Update Posted : March 7, 2016
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease Intervention/treatment Phase
Staphylococcus Lugdunensis Bacteremia Endocarditis Virulence Factors Genetic: Genetic blood sample Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Virulence of Staphylococcus Lugdunensis in Severe Infections
Study Start Date : December 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: Patient with infection by Staphylococcus lugdunensis Genetic: Genetic blood sample

Primary Outcome Measures :
  1. Presence/absence of virulence factors [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]

    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 :
  1. Clinical characteristics of infections [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
    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

  2. Whole human transcriptome analysis for selected patients [ Time Frame: Genetic blood samples will be analyzed together after the end of inclusion period (18 months) ]
  3. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT02026895

University Hospital
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Yves HANSMANN, MD University Hospital, Strasbourg, France

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT02026895     History of Changes
Other Study ID Numbers: 5616
First Posted: January 3, 2014    Key Record Dates
Last Update Posted: March 7, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Heart Diseases
Cardiovascular Diseases