Bacteremia, Diabetic Foot, Foot Ulcer, Infection, Leg Ulcer
Conditions
Keywords
S. aureus
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 description
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
Interventions
BIOLOGICALAntibody assays for S. aureus
Antibody assays for S. aureus at Day 0, Day 2, Day 4, Day 7, Day 30 and Month 6.
BIOLOGICALBasic blood work
Hemogramme + CRP on Days 0, 2, 4 and 7
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 6 months of follow up * Patients consulting at the departments of Diabetology, Dermatology or Infectious Diseases of the participating hospitals * inaugural or recurrent diabetic foot/ankle ulcers of Grade 2-4, or (2) who have an infected leg ulcer (arterial, venous, or mixed. Controls: * Absence of bacteriemia Cases: * Presence of bacteriemia
Exclusion criteria
* The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant, parturient, or breastfeeding * The patient does not have a chronic wound * Patient with grand 1 ulcer * Patient's wound/ulcer is not infected * Patient's would/ulcer is infected, but not involving S. aureus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Humoral immune response | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody production kinetics | 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 | 6 months | determined by microarrays |
Countries
France
Outcome results
None listed