Closed-loop Control of Penicillin Delivery Integrating Electrochemical Biosensor Technology
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Compare PK-PD target attainment between visits
研究概览
简要总结
This study is an in-house feasibility study of penicillin biosensor technology linked with closed-loop control for the automated delivery of penicillin antibiotics.
详细描述
Outline of the study:
This study will take place at the Imperial Clinical Research Facility (ICRF). Twenty healthy volunteers will be recruited to take part in three visits to the ICRF. These will each last 8-12 hours. During these visits participants will receive penicillin via infusion following:
(i) Routine (intermittent or continuous) dosing protocols. (ii) Intermittent dosing directed by a closed-loop control system. (iii) Continuous dosing directed by a closed-loop control system. Participants will have up to 15 blood samples and tissue microdialysis performed. A biosensor will also be used to provide real-time antibiotic concentration data. This will be used to drive the closed-loop control system. Outcome measures will be PK-PD target attainment between visits. This target will be 50% time > MIC and 100% time > MIC.
Participant 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 by the Healthy Volunteer Database Administrator and individuals responding will then followed up by telephone or e-mail and invited to attend a screening visit at the ICRF. They will be sent the participant information leaflet via email in advance of this meeting to give them time to consider the information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 adults, with no evidence of infection.
- •Previously received penicillin with no adverse effects.
排除标准
- •< 18 years old.
- •High risk of skin and soft tissue infection or local skin and soft tissue infection near sensor site.
- •Hypersensitivity to adhesive strips or active dermatitis.
- •Penicillin hypersensitivity 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).
- •Renal impairment on screening bloods (defined as a Cockcroft-Gault creatinine clearance <60mL/min).
- •Liver impairment on screening bloods (defined as ALT, ALP or bilirubin 3x ULN).
- •Implantable electronic device in-situ if wearing a microneedle array device.
- •Pregnant.
研究组 & 干预措施
Routine intermittent slow bolus
The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed. Benzylpenicillin IV 1200mg administered every 4 hours.
干预措施: Microneedle array (Device)
Routine intermittent slow bolus
The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed. Benzylpenicillin IV 1200mg administered every 4 hours.
干预措施: Penicillin G_1200mg (Drug)
Closed-loop control of intermittent slow bolus
The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed. Benzylpenicillin IV administered in intermittent dosing schedule. Dosage to be determined by closed-loop algorithm. Limits set to 2400mg every 4 hours.
干预措施: Microneedle array and closed-loop control of penicillin delivery (Device)
Closed-loop control of intermittent slow bolus
The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed. Benzylpenicillin IV administered in intermittent dosing schedule. Dosage to be determined by closed-loop algorithm. Limits set to 2400mg every 4 hours.
干预措施: Penicillin G_2400mg (Drug)
Closed-loop control of continuous infusion
The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed. Benzylpenicillin IV administered in continuous dosing schedule. Dosage to be determined by closed-loop algorithm. Initial loading dose, and limits set to 600mg/hr.
干预措施: Microneedle array and closed-loop control of penicillin delivery (Device)
Closed-loop control of continuous infusion
The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed. Benzylpenicillin IV administered in continuous dosing schedule. Dosage to be determined by closed-loop algorithm. Initial loading dose, and limits set to 600mg/hr.
干预措施: Penicillin G_600mg/hr (Drug)
结局指标
主要结局
Compare PK-PD target attainment between visits
时间窗: Up to 12 hours.
Compare time \> MIC between visits
Assessment of the biosensors ability to track benzylpenicillin 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 benzylpenicillin concentrations and microneedle data.
次要结局
未报告次要终点