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

NCT01551667 | Completed

• 2 other identifiers: AOI/2011/JPL-022011-A01400-41
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 6

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).

Conditions

Diabetic Foot; Foot Ulcer; Leg Ulcer; Bacteremia; Infection

Keywords

S. aureus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Antibody production kinetics

  6 months

• Presence / absence of clonal complexes of the S. aureus strains

  6 months

Study Arms (2)

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; Biological: Basic blood work

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; Biological: Basic blood work

Interventions

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.

Cases / bacteraemia; Controls

Basic blood work BIOLOGICAL

Hemogramme + CRP on Days 0, 2, 4 and 7

Cases / bacteraemia; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (6)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi

Le Grau-du-Roi, 30240, France

Location

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, 34295, France

Location

CHU de Nantes - Hôtel-Dieu

Nantes, 44093, France

Location

CHU de Nice - Hôpital Pasteur

Nice, 06002, France

Location

CHU de Nice - Hôpitaux L'Archet 1 et 2

Nice, 06202, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Left over blood/serum/plasma specimens will be incorporated into the biobank at the Bacteriology Laboratory of the Nîmes University Hospital

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer; Leg Ulcer; Bacteremia; Infections; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections

Study Officials

• Jean-Philippe Lavigne, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 13, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

FR (6)