Diabetic Foot, Staphylococcus Aureus
Conditions
Keywords
Antibiogramme, Antibiofilmogramme
Brief summary
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
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.
Interventions
BIOLOGICALAntibiofilmogramme
An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.
Sponsors
Centre Hospitalier Universitaire de Nīmes
BioFilm Control
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibiofilmogramme results | Baseline (Day 0) | Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance. |
| Antibiogram results | Baseline (Day 0) | Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance. |
| Presence/absence of S. aureus strains in the wound | At the end of 1st antibiotics (expected average of 21 days) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibiofilmogramme results | At the end of 1st antibiotics (expected average of 21 days) | Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance. |
| Antibiogram results | At the end of 1st antibiotics (expected average of 21 days) | Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance. |
| Wound surface area (mm^2) | Baseline (Day 0) | — |
| Wound depth (mm) | Baseline (Day 0) | — |
| 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 capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics | Baseline (Day 0) | Score varying from 0 to 80 |
| Presence/absence of S. aureus strains in the wound | Baseline | — |
Countries
France
Contacts
STUDY_DIRECTORAlbert Sotto, MD, PhD
Centre Hospitalier Universitaire de Nīmes
Outcome results
None listed