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

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

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).

Study Overview

• Status: Completed
• Conditions: Diabetic Foot; Foot Ulcer; Leg Ulcer; Bacteremia; Infection
• Intervention / Treatment: Biological: Antibody assays for S. aureus; Biological: Basic blood work

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

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• France
  • Le Grau du Roi, France, 30240
    • CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
  • Montpellier, France, 34295
    • CHU de Montpellier - Hopital Saint-Eloi
  • Nantes, France, 44093
    • CHU de Nantes - Hotel-Dieu
  • Nice, France, 06002
    • CHU de Nice - Hopital Pasteur
  • Nice, France, 06202
    • CHU de Nice - Hôpitaux L'Archet 1 et 2
  • Gard
    • Nîmes Cedex 09, Gard, France, 30029
      • CHU de Nîmes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Biological: Antibody assays for S. aureus; Antibody assays for S. aureus at Day 0, Day 2, Day 4, Day 7, Day 30 and Month 6.; Biological: Basic blood work; Hemogramme + CRP on Days 0, 2, 4 and 7
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.	Biological: Antibody assays for S. aureus; Antibody assays for S. aureus at Day 0, Day 2, Day 4, Day 7, Day 30 and Month 6.; Biological: Basic blood work; Hemogramme + CRP on Days 0, 2, 4 and 7

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Jean-Philippe Lavigne, MD PhD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: March 12, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: April 5, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: S. aureus
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Diabetic Foot; Foot Ulcer; Ulcer; Infections; Bacteremia; Wound Infection; Leg Ulcer; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: AOI/2011/JPL-02; 2011-A01400-41 (Other Identifier: RCB number)