Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections: a Prospective Mono-center Observational Pharmacological Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Delafloxacin concentration
研究概览
简要总结
The goal of this observational study is to measure how well the antibiotic delafloxacin penetrates into the blood and various body tissues in adult patients over 18 years old. Specifically, this study focuses on patients who are receiving the drug to treat bacterial infections and are undergoing surgery for post-sternotomy wound infections, mediastinitis, or infected prosthetic joints .
The main questions it aims to answer are:
- What is the concentration of delafloxacin in the blood plasma?
- What is the concentration of delafloxacin in different body tissues, including soft tissue, tissue around a prosthetic implant, joint fluid (synovial fluid), and bone ?
- How does the concentration of the drug in the blood compare to its concentration in the tissues?
- Do patient factors such as age, body weight, and kidney function affect the drug's levels in the body?
Participants will:
- Continue to receive delafloxacin (300mg intravenously every 12 hours) as prescribed by their treating physician for their infection.
- Allow researchers to draw 5 peripheral blood samples (about 10 mL total) at specific times (15 minutes, 1 hour, 3 hours, 5-7 hours, and 11 hours) after the end of a single delafloxacin infusion.
- Allow researchers to collect small amounts of tissue and joint fluid for testing during their already planned surgical procedure.
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
- •Participant is willing and able to give informed consent for participation in the study, and to be concurrently enrolled in the Institutional Infectious Disease Biobank (INDI-REBIO, NCT06418048)
- •>18 years-old
- •eGFR of > 80 mL/min/1,73m2
- •Receiving delafloxacin 300mg q12h IV according to treating physician's choice and good clinical practice or available guidelines with bacterial skin and skin structure infection and with
- •post-sternotomy wound infection and/or mediastinitis undergoing surgical debridement
- •prosthetic joint infections undergoing surgical debridement or prosthetic joint removal (either one-stage, e.g. when the Infected prosthesis is removed and a new one is implanted in the same surgery, or two-stage, when the Infected prosthesis is removed, followed by a period of antibiotics, then a new prosthesis is implanted in a second surgery).
排除标准
- •Patients who received other quinolones (oral or IV) in the week preceding the sample collection
- •Patients who decline or are unwilling to participate in serial blood draws at all five designated time points.
- •Pregnant or lactating women
研究组 & 干预措施
Prosthetic joint infections
Patients with prosthetic joint infections
干预措施: delafloxacin (Drug)
Post-sternotomy wound infection and/or mediastinits
Patients with post-sternotomy wound infection and/or mediastinits
干预措施: delafloxacin (Drug)
结局指标
主要结局
Delafloxacin concentration
时间窗: Peripheral blood samples drawn at 15 minutes, 1 hour, 3 hours, 5-7 hours, 11 hours after the end of delafloxacin infusion (delafloxacin infusion lasts approximately 1 hour). Tissue samples obtained according to patient's surgical plan.
Plasma concentration of delafloxacin Concentration of delafloxacin in tissues: * soft tissue * periprosthetic tissue * synovial fluid * bone (cancellous and cortical)
次要结局
未报告次要终点
研究者
Castagna Antonella
Professor
IRCCS San Raffaele