Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections

Study Overview
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Brief Summary
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This is an observational study that does not change routine care. The primary objective of this study is to investigate the role of antibiogramme-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in the presence/absence of S. aureus strains at the end of a first regimen of antibiotics.

Detailed Description
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The secondary objectives are: A. Should a first regimen of antibiotics fail, to describe the bacterial community present in the wound, and its potential to create biofilms. B. To investigate the role of antibiogramme-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in wound healing. C. To study the potential role of additional antibiofilmogramme data, as well as that of other pre-defined co-factors, in predicting wound changes. D. Create an S. aureus strain collection for future ancillary studies.

Official Title
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Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections

Conditions
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Diabetic Foot, Staphylococcus Aureus

Intervention / Treatment
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* Biological: Antibiofilmogramme


Participation Criteria
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Eligibility Criteria
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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 7 to 10 weeks of follow-up Patient with a foot wound (at least stage 2 or more) that is infected by at least 1 strain of S. aureus Exclusion Criteria: The patient is participating in, or has participated in within the past 3 months, another interventional study, or is currently in an exclusion period determined by a preceding 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 Emergency situation precluding correct study implementation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposure: Concordance between tests<br>The study population is composed of diabetic patients with foot wounds (at least stage >=2) that are infected by at least 1 strain of S. aureus. Patients whose antibiogrammes and Antibiofilmogrammes are concordant will fall into this group (the exposed group). Upon inclusion, 1) all patients' wounds will be sampled, and 2) the associated bacterial strains identified via Vitek and 3) antibiograms performed; the latter are all part of routine procedure. 4) S. aureus isolates will be further analysed via an antiobiofilmogramme, which is an experimental element added by this research. At the end of the 1st regimen of antibiotics prescribed, if the treatment failed steps 1 to 4 can be repeated. 30 days after the end of the 1st regimen of antibiotics prescribed, steps 1 to 4 are systematically performed. | Biological: Antibiofilmogramme<br>* An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.<br>|
| Non exposure: Not concordance between tests.<br>The study population is composed of diabetic patients with foot wounds (at least stage >=2) that are infected by at least 1 strain of S. aureus. Patients who do not fall into the concordance (exposure) group, will fall into the non exposure group. The latter includes semi-concordance or discordance between antibiogrammes and Antiobiofilmogrammes. Upon inclusion, 1) all patients' wounds will be sampled, and 2) the associated bacterial strains identified via Vitek and 3) antibiograms performed; the latter are all part of routine procedure. 4) S. aureus isolates will be further analysed via an antiobiofilmogramme, which is an experimental element added by this research. At the end of the 1st regimen of antibiotics prescribed, if the treatment failed steps 1 to 4 can be repeated. 30 days after the end of the 1st regimen of antibiotics prescribed, steps 1 to 4 are systematically performed. | Biological: Antibiofilmogramme<br>* An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of S. aureus strains in the wound |  | At the end of 1st antibiotics (expected average of 21 days) | 
| Antibiofilmogramme results | Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance. | Baseline (Day 0) | 
| Antibiogram results | Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance. | Baseline (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of S. aureus strains in the wound |  | Baseline | 
| Presence/absence of S. aureus strains in the wound |  | 30 days after end of 1st antibiotics (expected average of 51 days) | 
| Antibiofilmogramme results | Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance. | At the end of 1st antibiotics (expected average of 21 days) | 
| Antibiofilmogramme results | Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance. | 30 days after end of 1st antibiotics (expected average of 51 days) | 
| Antibiogram results | Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance. | At the end of 1st antibiotics (expected average of 21 days) | 
| Antibiogram results | Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance. | 30 days after end of 1st antibiotics (expected average of 51 days) | 
| Wound surface area (mm^2) |  | Baseline (Day 0) | 
| Wound surface area (mm^2) |  | At the end of 1st antibiotics (expected average of 21 days) | 
| Wound surface area (mm^2) |  | 30 days after end of 1st antibiotics (expected average of 51 days) | 
| Wound depth (mm) |  | Baseline (Day 0) | 
| Wound depth (mm) |  | At the end of 1st antibiotics (expected average of 21 days) | 
| Wound depth (mm) |  | 30 days after end of 1st antibiotics (expected average of 51 days) | 
| The surface area of the wound has decreased by 40% compared to initial size: yes/no. |  | 30 days after end of 1st antibiotics (expected average of 51 days) | 
| The number of bacterial strains detected in the wound. |  | Baseline (Day 0) | 
| The number of bacterial strains detected in the wound. |  | At the end of 1st antibiotics (expected average of 21 days) | 
| The number of bacterial strains detected in the wound. |  | 30 days after end of 1st antibiotics (expected average of 51 days) | 
| The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics | Score varying from 0 to 80 | Baseline (Day 0) | 
| The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics | Score varying from 0 to 80 | At the end of 1st antibiotics (expected average of 21 days) | 
| The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics | Score varying from 0 to 80 | 30 days after end of 1st antibiotics (expected average of 51 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiogramme, Antibiofilmogramme