Stool Biobanking and Impact of Antimicrobials on the Gut Microbiota in Patients With Bone and Joint Infection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 8
- 主要终点
- change in the gut microbiota after treatment
研究概览
简要总结
Bone and joint infections (BJI) is a public health issue in industrialized countries.
Implant-associated BJI, are complex hospital-acquired infections and eradication of the pathogen is challenging in such patients.
A prolonged antimicrobial therapy is usually required from 6 weeks to 3 months, but some patients are eligible to several years of treatment and most of patients report gastrointestinal troubles, such as nausea and mild to severe diarrhea (but very few developed C. difficile diarrhea).
Moreover, the host gut microbiota is probably largely affected in abundance, richness and diversity. Indeed, it is known, that few days of antibiotics are sufficient to induce significant alterations of the gut microbiota, also called dysbiosis.
Severe dysbiosis, which is potentially irreversible and associated with a definitive shift in the gut microbiota metabolism and host homeostasis, may lead to and/or promote a large panel of severe diseases such as Clostridium difficile infection, diabetes mellitus, obesity, inflammatory bowel disease (IBD), cirrhosis, neurological disorders and cancer. It may also be associated with BJI recurrence and then impact global health costs.
The main objective of this study is to constitute biobanking of stools and perform DNA sequencing of the gut microbiota in patients with acute or sub-acute implant-related Bone and Joint Infection (BJI), caused by Staphylococcus aureus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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 subject is willing, able to understand and comply to the protocol requirement
- •More than 18-years-old
- •Subject with suspicion of implant-related BJI within 3 months after surgery and treated by antibiotherapy for a maximal duration of six months
- •Subject signed Inform Consent Form
- •Contraception for women of childbearing age
排除标准
- •Severe disease with a life expectancy < 3months
- •Any antibiotherapy treated all diseases in the 14 days before inclusion
- •Guardianship, curatorship patients
- •Patient non-affiliated to health care system
- •Patient under the power of law
结局指标
主要结局
change in the gut microbiota after treatment
时间窗: from baseline to week 26
stools will be collected to perform DNA sequencing of the gut microbiota in patients with acute or sub-acute implant-related Bone and Joint Infection (BJI), caused by Staphylococcus aureus. Stools will be collected at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.
次要结局
- Assessment of the evolution of frequency of Diarrheic Symptoms(from baseline to week 8 or week 26)
- gut dysbiosis measured by Next Generation Sequencing (NGS)(from baseline to week 26)
- severe post-antibiotic dysbiosis (SPAD) measured by Next Generation Sequencing (NGS)(from baseline to week 26)
- Analysis of impact of Bone and Joint Infection on health-related quality of life in patients by EQ5D5L questionnaires(from baseline to week 26)
- Analysis of impact of Bone and Joint Infection on health-related quality of life in patients by EQ5D3L questionnaire(from baseline to week 26)
- Assessment of the evolution of intensity of Diarrheic Symptoms(from baseline to week 8 or week 26)
- Quantity of rectal acquisition of Multi Drug Resistance (MDR) bacteria under antibiotics measured by classic culture and quantification culture methods(at week 6 or week 24)
- Identification of markers of the gut dysbiosis (inflammatory proteins) measured by Elisa techniques(from baseline to week 26)