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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01551667
First received: March 6, 2012
Last updated: April 5, 2016
Last verified: April 2016
  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:


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

Enrollment: 69
Study Start Date: November 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (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 enrich the Nîmes University Hospital biobank
  • To evaluate the prevalence of different antibodies within each group
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, Gard, France, 30029
CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
Le Grau du Roi, France, 30240
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, France, 34295
CHU de Nantes - Hôtel-Dieu
Nantes, France, 44093
CHU de Nice - Hôpital Pasteur
Nice, France, 06002
CHU de Nice - Hôpitaux L'Archet 1 et 2
Nice, France, 06202
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Jean-Philippe Lavigne, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

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: April 5, 2016
Health Authority: France: 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:
Infection
Ulcer
Diabetic Foot
Foot Ulcer
Leg Ulcer
Bacteremia
Wound Infection
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Wounds and Injuries
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016