ElastoMeric Infusion Pumps for Hospital AntibioTICs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number (%) of consented inpatients who complete the planned course of intravenous antibiotics through an EMP
研究概览
简要总结
Special pumps called self-deflating Elastomeric Pumps (EMPs) will be tested for giving antibiotics via a drip to hospital patients. EMPs are filled with antibiotics, attached to a "drip" (usually in the arm) and worn on the body, slowly giving antibiotics through the day. EMPs are often used to give antibiotics to patients in their own home but they have not been used to treat patients in hospital before, so a small study of 10 patients will be conducted to see if a full scale clinical trial is worthwhile. EMPs will be tested for ease of use and safety in hospital, and to find out what staff and patients think about them. The pilot will be done to see if a clinical trial would be good value for money by comparing time spent in hospital, nursing time and overall cost to the NHS of the two ways of giving antibiotics to patients.
详细描述
4 Background 4.1 Antibiotic resistance Antibiotic resistance (AMR) is when bacteria have changed (mutated) so they can survive the effects of antibiotics, meaning antibiotics are less effective. AMR is a major threat to health worldwide. In UK hospitals, at least a third of patients are on antibiotics at any given time. Hospital patients with serious infections are often given intravenous antibiotics (through a "drip" into a vein). Cutting down unnecessary antibiotic prescribing is key to reducing resistance.
4.2 Problems giving intravenous antibiotics Giving intravenous antibiotics takes a lot of nursing time. This is made worse if antibiotics are needed more than once a day. Nurses are the only staff who give intravenous antibiotics in hospitals, and there is a shortage of 40,000 nurses in the NHS. Because of this, it is common for doses to be missed. The COVID-19 pandemic has increased the pressure on nurses' time. It is not always practical to give antibiotics 4 or 6 times a day so less effective antibiotics may be used instead.
4.3 What can be done to help? Some antibiotics work better when given slowly into a vein all the time. EMPs are self-powered devices that deliver antibiotics in this way.
EMPs:
- are currently used to give antibiotics to patients in their own homes
- are not used to give antibiotics to patients in hospitals because the safety, benefits and value for money have not been confirmed
- could allow more nurse time for patient care by reducing the time to set up antibiotic drips.
- could make things better for patients by allowing them to move more, sleep better, recover faster and spend less time in hospital
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
- 否
入选标准
- •Adult patients 18 years and over admitted to hospital with an infection requiring treatment for 7 days or more with intravenous flucloxacillin, piperacillin/tazobactam or benzylpenicillin Clinically stable and improving as assessed by the hospital medical consultant and likely to be well enough for discharge in the next two weeks.
- •Able to provide written consent or witnessed consent
排除标准
- •Unable to receive an appropriate vascular access device, such as a peripherally inserted central catheter (PICC) Penicillin allergy and unsuitable to receive penicillin challenge or desensitisation.
- •Requires a combination of intravenous antibiotics, any of which needs to be given more often than once daily.
- •Requires transfer to another hospital Unsuitable for outpatient parenteral antibiotic treatment
结局指标
主要结局
Number (%) of consented inpatients who complete the planned course of intravenous antibiotics through an EMP
时间窗: 6 months
次要结局
- Time (hrs) from identification of medically fit for discharge to actual discharge(6 months)
- Time (hrs) from electronic prescribing (with planned start date) of initial intravenous antibiotic to administration of first dose through EMP(6 months)
- Duration of hospital inpatient stay (days)(6 months)
- 30-day mortality(6 months)
- High residual volume in EMP (greater than 15% of 240mL = 36mL)(6 months)
- Number (%) of screened patients as identified by a microbiologist, antimicrobial pharmacist or the patient's clinical team(6 months)
- Time taken (hrs) to order, procure, deliver and administer antibiotics through EMPs(6 months)
- Number (%) of consented patients who receive ≥1 dose of EMP(6 months)
- Time (minutes) to order, procure, deliver and administer EMPs(6 months)
- Clinical cure (resolution of symptoms) assessed by hospital medical consultant(6 months)
- Number (%) of missed and delayed doses from beginning of antibiotic course, either with intermittent infusion or EMP(6 months)
- Number (%) of screened patients consented (recruitment)(6 months)
- Duration of total antibiotic course (days), including any early termination of planned treatment course and reason(6 months)
- Number of intravascular access devices required, including intermittent infusion period and EMP period(6 months)
- Description of antibiotic treatment pathway: intermittent, EMP, outpatient parenteral antibiotic therapy (OPAT), oral, cease(6 months)
研究者
Stuart Bond
Co-chief investigator
Mid Yorkshire Teaching NHS Trust