Clinical trial NCT01551667: Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds
Official title: Observational and Comparative Study on the Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds (Localized Infections Versus Bacteremia)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Foot Ulcer
Leg Ulcer
Bacteremia
Infection
Keywords: S. aureus
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Humoral immune response
timeFrame: 6 months
Secondary outcomes:
measure: Antibody production kinetics
timeFrame: 6 months
measure: Presence / absence of clonal complexes of the S. aureus strains
timeFrame: 6 months
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
city: Le Grau du Roi
country: France
facility: CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Saint-Eloi
city: Nantes
country: France
facility: CHU de Nantes - Hôtel-Dieu
city: Nice
country: France
facility: CHU de Nice - Hôpital Pasteur
city: Nice
country: France
facility: CHU de Nice - Hôpitaux L'Archet 1 et 2
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean-Philippe Lavigne, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: