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

Completed

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

• 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

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