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 ]
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