Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 12
- 主要终点
- Presence/absence of S. aureus strains in the wound
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Exposure: Concordance between tests
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.
干预措施: Antibiofilmogramme (Biological)
Non exposure: Not concordance between tests.
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.
干预措施: Antibiofilmogramme (Biological)
结局指标
主要结局
Presence/absence of S. aureus strains in the wound
时间窗: At the end of 1st antibiotics (expected average of 21 days)
Antibiofilmogramme results
时间窗: Baseline (Day 0)
Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.
Antibiogram results
时间窗: Baseline (Day 0)
Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.
次要结局
- 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 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))
- 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))
- Antibiogram results(30 days after end of 1st antibiotics (expected average of 51 days))
- 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 number of bacterial strains detected in the wound.(30 days after end of 1st antibiotics (expected average of 51 days))
- Presence/absence of S. aureus strains in the wound(Baseline)
- Antibiofilmogramme results(At the end of 1st antibiotics (expected average of 21 days))
- Antibiogram results(At the end of 1st antibiotics (expected average of 21 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 depth (mm)(Baseline (Day 0))
- Wound depth (mm)(At the end of 1st antibiotics (expected average of 21 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 capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics(Baseline (Day 0))
- The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics(At the end of 1st antibiotics (expected average of 21 days))