Virulence of Staphylococcus Lugdunensis in Severe Infections

Bacteremia Clinical Trial

— VISLISI  

Official title:

Virulence of Staphylococcus Lugdunensis in Severe Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026895
• Other study ID #: 5616
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: March 4, 2016
• Start date: December 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bacteremia
• Endocarditis
• Staphylococcus Lugdunensis
• Virulence Factors

Intervention

Genetic:
• Genetic blood sample

Locations

Country	Name	City	State
France	University Hospital	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participants will be followed for the duration of hospital stay, an expected average of 1 week	Yes
Secondary	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	Participants will be followed for the duration of hospital stay, an expected average of 1 week	No
Secondary	Whole human transcriptome analysis for selected patients		Genetic blood samples will be analyzed together after the end of inclusion period (18 months)	No
Secondary	Genome sequencing of selected strains of Staphylococcus lugdunensis		Genetic blood samples will be analyzed together after the end of inclusion period (18 months)	No