Microneedle Sensing of Beta-lactam Antibiotic Concentrations in Human Interstitial Fluid
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Assessment of the Biosensors Ability to Track Phenoxymethylpenicillin Concentrations Compared to Observations Made by Microdialysis and Blood Sampling
研究概览
简要总结
This study is an in-house feasibility study of a microneedle biosensor developed within Imperial College London.
详细描述
Outline of the study:
This study will comprise the recruitment of 10-15 healthy volunteers. They will be recruited to test the microneedle biosensors and undergo rich plasma sampling with or without tissue microdialysis to calibrate the microneedle biosensor and evaluate its accuracy against current gold standards (i.e. plasma drug concentration and tissue microdialysis). This study will take place at the Imperial Clinical Research Facility (CRF).
Patient identification:
Healthy volunteers will be recruited from a healthy volunteer database held within Imperial College London and via identification of participants within the College. An initial advertisement e-mail will be sent and individuals responding will then followed up by telephone and invited to attend a screening visit at the Imperial CRF. They will be sent the participant information leaflet in advance of this meeting to give them time to consider the information. At this visit a member of the research team will go through the study procedure and answer any questions that the participant has.
Consent procedure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •Adult >18 years old
- •Healthy with no evidence of active infection
- •Previously received penicillin with no adverse effects
排除标准
- •High risk of skin soft tissue infection or local skin and soft tissue infection near sensor site
- •Previous history of allergies to adhesive strips or active dermatitis
- •Penicillin allergy or previous adverse event whilst receiving penicillin
- •Anaemia on screening bloods (defined as haemoglobin <13 g/dL in males and <12 g/dL in females)
研究组 & 干预措施
Healthy volunteer
干预措施: Phenoxymethyl Penicillin (Drug)
Healthy volunteer
干预措施: Microneedle array (Device)
结局指标
主要结局
Assessment of the Biosensors Ability to Track Phenoxymethylpenicillin Concentrations Compared to Observations Made by Microdialysis and Blood Sampling
时间窗: Up to 12 hours
Bland-Altman plot to describe agreement between interstitial phenoxymethylpenicillin concentrations and microneedle data (mean difference between microneedle and microdialysis measurements)
次要结局
未报告次要终点