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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01400-41 | Other Identifier | RCB number |
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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).
Secondary objectives include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases / bacteraemia | 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. |
| |
| Controls | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibody assays for S. aureus | Biological | Antibody assays for S. aureus at Day 0, Day 2, Day 4, Day 7, Day 30 and Month 6. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Controls:
Cases:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe Lavigne, MD PhD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | Gard | 30029 | France | ||
| CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D016470 | Bacteremia |
| D007239 | Infections |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012883 | Skin Ulcer |
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Left over blood/serum/plasma specimens will be incorporated into the biobank at the Bacteriology Laboratory of the Nîmes University Hospital
| Basic blood work | Biological | Hemogramme + CRP on Days 0, 2, 4 and 7 |
|
determined by microarrays |
| 6 months |
| Le Grau-du-Roi |
| 30240 |
| France |
| CHU de Montpellier - Hôpital Saint-Eloi | Montpellier | 34295 | France |
| CHU de Nantes - Hôtel-Dieu | Nantes | 44093 | France |
| CHU de Nice - Hôpital Pasteur | Nice | 06002 | France |
| CHU de Nice - Hôpitaux L'Archet 1 et 2 | Nice | 06202 | France |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D005534 | Foot Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |