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

Infection Clinical Trial

— ORISA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551667
• Other study ID #: AOI/2011/JPL-02
• Secondary ID: 2011-A01400-41
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: April 5, 2016
• Start date: November 2012
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacteremia
• Diabetic Foot
• Foot Ulcer
• Infection
• Leg Ulcer
• Ulcer
• Wound Infection

Intervention

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.
• Basic blood work
Hemogramme + CRP on Days 0, 2, 4 and 7

Locations

Country	Name	City	State
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	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Presence / absence of clonal complexes of the S. aureus strains	determined by microarrays	6 months	No