Clinical trial NCT02026895: Virulence of Staphylococcus Lugdunensis in Severe Infections
Official title: Virulence of Staphylococcus Lugdunensis in Severe Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Staphylococcus Lugdunensis
Bacteremia
Endocarditis
Virulence Factors
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Presence/absence of virulence factors
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary outcomes:
measure: Clinical characteristics of infections
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Whole human transcriptome analysis for selected patients
timeFrame: Genetic blood samples will be analyzed together after the end of inclusion period (18 months)
measure: Genome sequencing of selected strains of Staphylococcus lugdunensis
timeFrame: Genetic blood samples will be analyzed together after the end of inclusion period (18 months)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Yves HANSMANN, MD
role: PRINCIPAL_INVESTIGATOR
References: