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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Diabetic Foot, Foot Ulcer, Leg Ulcer, Bacteremia, Infection

Intervention / Treatment
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* Biological: Antibody assays for S. aureus
* Biological: Basic blood work


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases / bacteraemia<br>Patients consulting at the departments of Diabetology, Dermatology or Infectious Diseases of the participating hospitals and who have (1) inaugural or recurrent diabetic foot/ankle ulcers of Grade 2-4, or (2) who have an infected leg ulcer (arterial, venous, or mixed. This infection must involve S. aureus in a mono-or polymicrobial setting. This group of patients has bacteraemia. | Biological: Antibody assays for S. aureus<br>* Antibody assays for S. aureus at Day 0, Day 2, Day 4, Day 7, Day 30 and Month 6.<br>Biological: Basic blood work<br>* Hemogramme + CRP on Days 0, 2, 4 and 7<br>|
| Controls<br>Patients consulting at the departments of Diabetology, Dermatology or Infectious Diseases of the participating hospitals and who have (1) inaugural or recurrent diabetic foot/ankle ulcers of Grade 2-4, or (2) who have an infected leg ulcer (arterial, venous, or mixed. This infection must involve S. aureus in a mono-or polymicrobial setting. This group of patients does not have bacteraemia. | Biological: Antibody assays for S. aureus<br>* Antibody assays for S. aureus at Day 0, Day 2, Day 4, Day 7, Day 30 and Month 6.<br>Biological: Basic blood work<br>* Hemogramme + CRP on Days 0, 2, 4 and 7<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humoral immune response | 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). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody production kinetics | 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. | 6 months | 
| Presence / absence of clonal complexes of the S. aureus strains | determined by microarrays | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S. aureus