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Completed

NCT Number: NCT01551667

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

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).

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibody assays for S. aureus

Biological

Antibody assays for S. aureus at Day 0, Day 2, Day 4, Day 7, Day 30 and Month 6.

Basic blood work

Biological

Hemogramme + CRP on Days 0, 2, 4 and 7

Primary outcomes

  1. Humoral immune response

    Time frame: 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 outcomes

  1. Antibody production kinetics

    Time frame: 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.

  2. Presence / absence of clonal complexes of the S. aureus strains

    Time frame: 6 months

    determined by microarrays

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: ORISA

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2012
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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