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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Infection; Diabetic Foot; Foot Ulcer; Bacteremia; Leg Ulcer

Treatments: Biological: Basic blood work; Biological: Antibody assays for S. aureus

Study type: Observational

Funder types: Other

Identifiers

NCT01551667

AOI/2011/JPL-02

2011-A01400-41 (Other Identifier)

Details and patient eligibility

About

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).

Full 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

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

69 participants in 2 patient groups

Cases / bacteraemia

Description:

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.

Treatment:

Biological: Antibody assays for S. aureus

Biological: Basic blood work

Controls

Description:

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.

Treatment:

Biological: Antibody assays for S. aureus

Biological: Basic blood work