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

This study is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01551667
First received: March 6, 2012
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

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).


Condition Intervention
Diabetic Foot
Foot Ulcer
Leg Ulcer
Bacteremia
Infection
 Biological: Antibody assays for S. aureus
Biological: Basic blood work

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observational and Comparative Study on the Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds (Localized Infections Versus Bacteremia)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Humoral immune response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Antibody production kinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    determined by microarrays


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


Estimated Enrollment: 76
Study Start Date: September 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Antibody assays for S. aureus at Day 0, Day 2, Day 4, Day 7, Day 30 and Month 6.
Biological: Basic blood work
Hemogramme + CRP on Days 0, 2, 4 and 7
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
Antibody assays for S. aureus at Day 0, Day 2, Day 4, Day 7, Day 30 and Month 6.
Biological: Basic blood work
Hemogramme + CRP on Days 0, 2, 4 and 7

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 enriching the Nîmes University Hospital biobank
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551667

Contacts
Contact: Jean-Philippe Lavigne, MD PhD +33.(0)4.66.68.32.02 jphlavigne@hotmail.com
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, Gard, France, 30029
Principal Investigator: Jean-Philippe Lavigne, MD PhD            
Sub-Investigator: Albert Sotto, MD PhD            
Sub-Investigator: Laurent Meunier, MD PhD            
Sub-Investigator: Nathalie Jourdan, MD            
Sub-Investigator: Sophie Schuldiner, MD            
Sub-Investigator: Pierre Corbeau, MD PhD            
APHP - Hôpital Charles Foix Not yet recruiting
Ivry Sur Seine Cedex, France, 94205
Sub-Investigator: Sylvier Meaume, MD            
Sub-Investigator: Laurence Drieux, MD            
CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi Recruiting
Le Grau du Roi, France, 30240
Sub-Investigator: Jean Louis Richard, MD            
CHU de Montpellier - Hôpital Saint-Eloi Recruiting
Montpellier, France, 34295
Sub-Investigator: Olivier Dereure, MD PhD            
CHU de Nice - Hôpitaux L'Archet 1 et 2 Recruiting
Nice, France, 06202
Sub-Investigator: Luce Landraud, MD            
CHU de Nice - Hôpital Pasteur Recruiting
Nice, France, 06002
Sub-Investigator: Bertrand Canivet, MD PhD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Jean-Philippe Lavigne, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01551667     History of Changes
Other Study ID Numbers: AOI/2011/JPL-02, 2011-A01400-41
Study First Received: March 6, 2012
Last Updated: March 22, 2013
Health Authority: France: L’Agence nationale de sécurité du médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
S. aureus

Additional relevant MeSH terms:
Leg Ulcer
Bacteremia
Ulcer
Wound Infection
Foot Ulcer
Diabetic Foot
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Skin Ulcer
Skin Diseases
 Wounds and Injuries
Foot Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013