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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02026895
Other study ID # 5616
Secondary ID
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


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
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