Investigation of the Microbiome of Patients Receiving Antibiotic Therapy for Orthopedic Device-related Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Composition of the the gut microbiota following two weeks of intravenous antibiotic therapy
研究概览
简要总结
The microbiome of 80 orthopedic-device related infection (ODRI) patients treated with antibiotics and 10 healthy controls will be investigated. Samples (blood, stool, saliva, skin-swab) are collected 4x within 6 months. Composition and diversity of the microbiome will be assessed by 16sRNA sequencing, skins swabs are screened for rifampicin-resistant staphylococci onto Mannitol-salt-agar plates supplemented with rifampicin, inflammation markers and antibodies in blood and saliva are monitored to track changes in the immune response. For further analysis patients are assigned to one of two groups: 1) antibiotic therapy including rifampicin and 2) non-rifampicin antibiotic therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 is planned to undergo revision surgery due to suspected bone or joint infection.
- •The patient is at least 18 years old
排除标准
- •The patient took antibiotics in the previous six weeks of recruitment (a single dose/"shot" of antibiotics during this period is not considered).
- •The patient suffers from gut-associated morbidities such as Morbus Crohn or colitis ulcerosa.
- •The patient suffers from psychiatric disorders/cognitive impairment affecting understanding.
- •The patient is unable to give consent and follow procedures and/or has insufficient knowledge of the project language.
结局指标
主要结局
Composition of the the gut microbiota following two weeks of intravenous antibiotic therapy
时间窗: Two weeks
The gut microbiota will be characterized by means of 16s rRNA sequencing. The gut microbiota composition following two weeks of intravenous (iv) antibiotic treatment will be compared to baseline samples of the patients.
Composition of the gut microbiota following four weeks of oral antibiotic therapy
时间窗: Six weeks (including two weeks iv and four weeks of oral antibiotic therapy)
The gut microbiota will be characterized by means of 16s rRNA sequencing. The gut microbiota composition following four weeks of oral antibiotic treatment will be compared to baseline samples of the patients.
Composition of the gut microbiota 24 weeks after antibiotic therapy start
时间窗: 24 weeks
The gut microbiota will be characterized by means of 16s rRNA sequencing. The gut microbiota composition 24 weeks after antibiotic therapy start, including an at least 6-week antibiotic free period, will be compared to baseline samples of the patients.
次要结局
- Monitoring Rifampicin resistant S. aureus on the skin following two weeks of iv antibiotic therapy(Two weeks)
- Monitoring Rifampicin resistant S. aureus on the skin following four weeks of oral antibiotic therapy(Six weeks (including two weeks iv and four weeks of oral antibiotic therapy))
- Monitoring Rifampicin resistant S. aureus on the skin 24 weeks after antibiotic therapy start(24 weeks)