Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections
- Conditions
- Staphylococcus AureusDiabetic Foot
- Interventions
- Biological: Antibiofilmogramme
- Registration Number
- NCT02378493
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Exposure: Concordance between tests Antibiofilmogramme 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. Antibiofilmogramme 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.
- Primary Outcome Measures
Name Time Method Presence/absence of S. aureus strains in the wound At the end of 1st antibiotics (expected average of 21 days) 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.
- Secondary Outcome Measures
Name Time Method 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) Presence/absence of S. aureus strains in the wound 30 days after end of 1st antibiotics (expected average of 51 days) Antibiofilmogramme results 30 days after end of 1st antibiotics (expected average of 51 days) Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.
Antibiogram results 30 days after end of 1st antibiotics (expected average of 51 days) Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.
Wound surface area (mm^2) 30 days after end of 1st antibiotics (expected average of 51 days) Wound depth (mm) 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 30 days after end of 1st antibiotics (expected average of 51 days) Score varying from 0 to 80
The number of bacterial strains detected in the wound. 30 days after end of 1st antibiotics (expected average of 51 days)
Trial Locations
- Locations (6)
CHU de Clermont-Ferrand - Hôpital Gabriel-Montpied
🇫🇷Clermont Ferrand, France
CHRU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France
CHU
🇫🇷Nantes, France
CHRU de Strasbourg - Hôpital Civil
🇫🇷Strasbourg Cedex, France
CHU de Lyon - Hôpital de la Croix-Rousse
🇫🇷Lyon Cedex 4, France
CHU de Lyon - Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France