Diabetic FootORISANCT01551667
Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds
An observational study of Diabetic Foot and Foot Ulcer, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Foot Ulcer, Leg Ulcer
- What is being tested?
- Antibody assays for S. aureus and Basic blood work
- How many people
- 69 participants
- Where
- 6 sitesFrance
- Study dates
- Nov 2012to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
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- Absence of bacteriemia
- Cases:
- Presence of bacteriemia
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
Le Grau-du-Roi, 30240
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, 34295
CHU de Nantes - Hôtel-Dieu
Nantes, 44093
CHU de Nice - Hôpital Pasteur
Nice, 06002
CHU de Nice - Hôpitaux L'Archet 1 et 2
Nice, 06202
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, 30029
About this study
Official title: Observational and Comparative Study on the Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds (Localized Infections Versus Bacteremia)
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).
Read the 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
- Conditions
- Diabetic Foot, Foot Ulcer, Leg Ulcer, Bacteremia, Infection
- Being tested
- Antibody assays for S. aureus, Basic blood work
- Keywords
- S. aureus
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Leg Ulcer, Bacteremia, Infections, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibody assays for S. aureusBiological
Antibody assays for S. aureus at Day 0, Day 2, Day 4, Day 7, Day 30 and Month 6.
Basic blood workBiological
Hemogramme + CRP on Days 0, 2, 4 and 7
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Antibody assays for S. aureus; Biological: Basic blood work | |
| 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. Receives: Biological: Antibody assays for S. aureus; Biological: Basic blood work |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
Presence / absence of clonal complexes of the S. aureus strains
determined by microarrays
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Lavigne, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551667
- Sponsor's protocol ID
- AOI/2011/JPL-02
- Other IDs
- 2011-A01400-41
- Acronym
- ORISA
- Status last verified
- Apr 2016
- First submitted
- 6 Mar 2012
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational and Comparative Study on the Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds (Localized Infections Versus Bacteremia)
- ClinicalTrials.gov ID
- NCT01551667
- Acronym / sponsor ID
- ORISA / AOI/2011/JPL-02
- Conditions
- Diabetic Foot, Foot Ulcer, Leg Ulcer, Bacteremia, Infection
- Keywords
- S. aureus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases / bacteraemia | – | Biological: Antibody assays for S. aureus, Biological: Basic blood workPatients 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. |
| Controls | – | Biological: Antibody assays for S. aureus, Biological: Basic blood workPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibody assays for S. aureusAntibody assays for S. aureus at Day 0, Day 2, Day 4, Day 7, Day 30 and Month 6. | Biological | Cases / bacteraemia, Controls |
| Basic blood workHemogramme + CRP on Days 0, 2, 4 and 7 | Biological | Cases / bacteraemia, Controls |
Primary outcome
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).
2 secondary outcomes
Antibody production kinetics
Time frame: 6 months
Presence / absence of clonal complexes of the S. aureus strains
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe Lavigne, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot and Foot Ulcer, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral immune response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.