Demonstration of Clinical Value of Antibiofilmogramme Test for Monomicrobial S. Aureus Orthopaedic Device-Related Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Success or treatment failure
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 correlation between the administration of an antibiotherapy able to prevent biofilm formation according to the results of the Antibiofilmogramme test, and the relapse of the infection for patient with orthopaedic device-related infection.
详细描述
The secondary objectives are:
A. Investigate the role of antibiogram-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in orthopaedic device-related infection management.
B. Investigate the capacity of S. aureus isolates to form biofilm in presence/absence of antibiotics.
C. Create an S. aureus strain collection for future ancillary studies
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 been informed and received a non-opposition consent form
- •Patient with a monomicrobial S. aureus bone and joint infections
- •Patient with prosthetic or orthopaedic device
排除标准
- •Bone and joint infection from pressure ulcer, vascular injury or diabetic foot ulcer
- •Polymicrobial prosthetic joint infection
- •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
- •Patient is under judicial protection, under tutorship or curatorship
- •The patient expresses his opposition to participate to the study
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient or breastfeeding
- •Emergency situation precluding correct study implementation
结局指标
主要结局
Success or treatment failure
时间窗: From surgical intervention to one year after the end of antimicrobial therapy.
Presence or absence of microbiological treatment failure confirmed by S. aureus positive clinical samples. The diagnostic of a S. aureus positive clinical sample indicated a treatment failure. Treatment success corresponded to an absence of clinical or microbiological treatment failure, or treatment failure with positive clinical sample other than S. aureus.
次要结局
未报告次要终点