Clinical Trial: Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Observational and Comparative Study on the Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds (Localized Infections Versus Bacteremia)

Brief Summary: The primary objective of this study is to detect differences in anti-S. aureus antibody assays (IgM, IgA, IgG and its subclasses) between (1) a group of patients with bacteremia due to a chronic wound (cases) and (2) a group of patients with localized chronic wound infections (control).

Detailed Summary:

Secondary objectives include:

  • To propose a diagnostic marker of bacteraemia based on the detection of anti-S. aureus by xMAP technology
  • To evaluate the kinetics of the humoral immune response to S. aureus in patients with bacteraemia
  • To evaluate the virulence of S. aureus isolated from chronic, infected wounds
  • To enrich the Nîmes University Hospital biobank
  • To evaluate the prevalence of different antibodies within each group

Sponsor: Centre Hospitalier Universitaire de Nīmes

Current Primary Outcome: Humoral immune response [ Time Frame: 6 months ]

Humoral immune response via production of anti-staphylococci antibodies in patients with bacteraemia versus those with localized wound infections. 22 antibodies will be tested(quantitative determination by xMAP technology).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Antibody production kinetics [ Time Frame: 6 months ]
    Kinetics of the production of the 22 antibodies against S. aureus in the 2 groups. The temporal evolution of antibody titres determined via xMAP technology will be followed throughout the study.
  • Presence / absence of clonal complexes of the S. aureus strains [ Time Frame: 6 months ]
    determined by microarrays


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nīmes

Dates:
Date Received: March 6, 2012
Date Started: November 2012
Date Completion:
Last Updated: April 5, 2016
Last Verified: April 2016