Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01745-42 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BioFilm Control | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure: Concordance between tests | Experimental | 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. |
|
| Non exposure: Not concordance between tests. | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiofilmogramme | Biological | An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate. |
| 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) |
| 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) | |
| Measure | Description | Time Frame |
|---|---|---|
| Age (years) | Baseline (Day 0) | |
| Sex (m/f) | Baseline (Day 0) | |
| Body mass index (kg/m^2) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Albert Sotto, MD, PhD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand - Hôpital Gabriel-Montpied | Clermont-Ferrand | 63003 | France | |||
| CHU de Lyon - Hôpital de la Croix-Rousse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27399775 | Background | Dunyach-Remy C, Ngba Essebe C, Sotto A, Lavigne JP. Staphylococcus aureus Toxins and Diabetic Foot Ulcers: Role in Pathogenesis and Interest in Diagnosis. Toxins (Basel). 2016 Jul 7;8(7):209. doi: 10.3390/toxins8070209. | |
| 34945223 | Result | Sotto A, Laurent F, Schuldiner S, Vouillarmet J, Corvec S, Bemer P, Boutoille D, Dunyach-Remy C, Lavigne JP. Evaluation of the Use of Antibiofilmogram Technology in the Clinical Evolution of Foot Ulcers Infected by Staphylococcus aureus in Persons Living with Diabetes: A Pilot Study. J Clin Med. 2021 Dec 17;10(24):5928. doi: 10.3390/jcm10245928. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
| Baseline (Day 0) |
| Antiobiotics taken | During the treatment period (expected average of 21 days) |
| % glycated hemoglobin | 30 days after end of 1st antibiotics (expected average of 51 days) |
| Systolic pressure index at the toe (ratio) | Baseline (Day 0) |
| Perception threshold for vibrations at the ankle (Hz) | Baseline (Day 0) |
| Lyon |
| 69317 |
| France |
| CHU | Nantes | France |
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| CHU de Lyon - Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| CHRU de Strasbourg - Hôpital Civil | Strasbourg | 67091 | France |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |