Point of Care Testing Using FebriDx to Improve Antibiotic Use for Respiratory Tract Infections in Primary Care: a Mixed Methods Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Ease-of-use scores
研究概览
简要总结
This is a mixed-methods, multi-centre feasibility study. Formal advice and peer-review with regards to study design was sought from the Southampton Research Design Service (RDS), the NIHR CRN Wessex, and patient contributors during the development of the grant application. We will recruit up to ten GP practices, each given 20-40 FebriDx tests (300 in total). Up to four clinicians per practice will be trained to use the test. A sequential explanatory approach to data collection will be taken (21), with quantitative data analysis in stage one, followed by qualitative interviews with the study's practice participants in stage two.
详细描述
It can be difficult to tell the difference between viral and bacterial infections. Many patients are therefore prescribed antibiotics unnecessarily. Overuse of antibiotics is leading to a crisis of 'antibiotic resistance', where antibiotics no longer work for some infections.
FebriDx ® is a new hand-held test that uses a 'finger-prick' of blood, and within 10 minutes, provides a result that can help clinicians decide whether an infection is likely to be caused by a virus or bacteria. This could help clinicians decide when antibiotics are needed, but the test has not been adequately tested in primary care.
We would like to do a future study to test whether FebriDx can safely reduce antibiotic prescriptions in primary care.
However, before we do this, we need to do a smaller 'feasibility' study to explore how easy to use the FebriDx test is and, what GPs and patients think of the test, and to help us design a larger future study.
Aims
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower respiratory tract infection (defined as in previous studies as an acute cough as the predominant symptom, judged by the GP to be infective in origin, lasting <21 days, and with other symptoms or signs localising to the lower respiratory tract (shortness of breath, sputum, chest pain). This is a definition which we have used in previous studies (22)
- •The clinician has decided that they are likely to prescribe antibiotics in the absence of further diagnostic testing
- •The patient is at the surgery or willing to attend the surgery for a face-to-face assessment
- •The patient (or their parent or legal guardian) can follow the study procedures and is willing to provide informed consent
排除标准
- •Patients who have taken antibiotics within the last 30 days
- •Participant (or their parent/guardian) unable to provide informed consent
结局指标
主要结局
Ease-of-use scores
时间窗: Six months
The average ease-of-use score for the device as determined by users. Each user will be asked to grade the device according to a modified US Clinical Laboratory Improvement Amendments (CLIA) categorisation criteria Within each of the 11 categories, a score of '1' indicates the lowest level of complexity, and the score of '3' indicates the highest level, to derive a measure of complexity (total score range 1 - 33)
Subsequent healthcare contacts
时间窗: Within 30 days of recruitment
The proportion of patients undergoing subsequent healthcare contact
Recruitment rate
时间窗: Six months
The proportion of patients recruited as compared to the number invited to participate
Test failure rate
时间窗: After FebriDx use (baseline)
The proportion of Febridx tests which fail to provide a valid result
Antibiotic prescription rate at study visit
时间窗: At study visit (baseline)
The proportion of patients prescribed antibiotics at the study visit
Antibiotic prescription rate over entire study period
时间窗: Within 30 days of recruitment
The proportion of patients prescribed antibiotics within 30 days of recruitment
Subsequent serious complication rate
时间窗: Within 30 days of recruitment
The proportion of patients undergoing significant complications (sepsis, ITU admission, or death)
次要结局
- FebriDx sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for diagnosis of viral infection(Within one year)