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

Completed

• Conditions: Bacteremia; Infection; Foot Ulcer; Leg Ulcer; Diabetic Foot
• Interventions: Biological: Antibody assays for S. aureus; Biological: Basic blood work

• Registration Number: NCT01551667
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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).

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 Timeline

• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-13
• Study Start: 2012-11
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Basic blood work	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.
Cases / bacteraemia	Basic blood work	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	Antibody assays for S. aureus	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.
Cases / bacteraemia	Antibody assays for S. aureus	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.

Primary Outcome Measures

Name	Time	Method
Humoral immune response	6 months	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).

Secondary Outcome Measures

Name	Time	Method
Antibody production kinetics	6 months	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.
Presence / absence of clonal complexes of the S. aureus strains	6 months	determined by microarrays

Trial Locations

Locations (6)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, Gard, France

CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi; 🇫🇷 Le Grau du Roi, France

CHU de Montpellier - Hôpital Saint-Eloi; 🇫🇷 Montpellier, France

CHU de Nantes - Hôtel-Dieu; 🇫🇷 Nantes, France

CHU de Nice - Hôpital Pasteur; 🇫🇷 Nice, France

CHU de Nice - Hôpitaux L'Archet 1 et 2; 🇫🇷 Nice, France