Virulence of Staphylococcus Lugdunensis in Severe Infections

NCT02026895 | Completed DMC

• 1 other identifier: 5616
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcus Lugdunensis; Bacteremia; Endocarditis; Virulence Factors

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Clinical characteristics of infections

  Participants will be followed for the duration of hospital stay, an expected average of 1 week

• Whole human transcriptome analysis for selected patients

  Genetic blood samples will be analyzed together after the end of inclusion period (18 months)

• Genome sequencing of selected strains of Staphylococcus lugdunensis

  Genetic blood samples will be analyzed together after the end of inclusion period (18 months)

Study Arms (1)

Patient with infection by Staphylococcus lugdunensis

EXPERIMENTAL

Genetic: Genetic blood sample

Interventions

Genetic blood sample GENETIC

Patient with infection by Staphylococcus lugdunensis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age under 18
• Pregnancy or breastfeeding
• Contamination by Staphylococcus lugdunensis

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

University Hospital

Strasbourg, 67091, France

Location

Related Publications (4)

• Argemi X, Martin V, Loux V, Dahyot S, Lebeurre J, Guffroy A, Martin M, Velay A, Keller D, Riegel P, Hansmann Y, Paul N, Prevost G. Whole-Genome Sequencing of Seven Strains of Staphylococcus lugdunensis Allows Identification of Mobile Genetic Elements. Genome Biol Evol. 2017 May 1;9(5). doi: 10.1093/gbe/evx077.

  PMID: 28444231 RESULT

• Argemi X, Prevost G, Riegel P, Provot C, Badel-Berchoux S, Jehl F, Olivares E, Hansmann Y. Kinetics of biofilm formation by Staphylococcus lugdunensis strains in bone and joint infections. Diagn Microbiol Infect Dis. 2017 Aug;88(4):298-304. doi: 10.1016/j.diagmicrobio.2017.05.002. Epub 2017 May 12.

  PMID: 28529089 RESULT

• Argemi X, Matelska D, Ginalski K, Riegel P, Hansmann Y, Bloom J, Pestel-Caron M, Dahyot S, Lebeurre J, Prevost G. Comparative genomic analysis of Staphylococcus lugdunensis shows a closed pan-genome and multiple barriers to horizontal gene transfer. BMC Genomics. 2018 Aug 20;19(1):621. doi: 10.1186/s12864-018-4978-1.

  PMID: 30126366 RESULT

• Argemi X, Hansmann Y, Prola K, Prevost G. Coagulase-Negative Staphylococci Pathogenomics. Int J Mol Sci. 2019 Mar 11;20(5):1215. doi: 10.3390/ijms20051215.

  PMID: 30862021 RESULT

MeSH Terms

Conditions

Bacteremia; Endocarditis

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Yves HANSMANN, MD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: January 3, 2014
• Study Start: December 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

FR (1)