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Virulence of Staphylococcus Lugdunensis in Severe Infections (VISLISI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT02026895
First received: December 9, 2013
Last updated: March 4, 2016
Last verified: March 2016
  Purpose
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 Intervention
Staphylococcus Lugdunensis
Bacteremia
Endocarditis
Virulence Factors
Genetic: Genetic blood sample

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Virulence of Staphylococcus Lugdunensis in Severe Infections

Further study details as provided by University Hospital, Strasbourg, France:

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

    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 [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ] [ Designated as safety issue: No ]
    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 [ Time Frame: Genetic blood samples will be analyzed together after the end of inclusion period (18 months) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: December 2013
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient with infection by Staphylococcus lugdunensis Genetic: Genetic blood sample

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026895

Locations
France
University Hospital
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Yves HANSMANN, MD University Hospital, Strasbourg, France
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02026895     History of Changes
Other Study ID Numbers: 5616 
Study First Received: December 9, 2013
Last Updated: March 4, 2016
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Bacteremia
Endocarditis
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 05, 2016