ISRCTN16039192进行中（未招募）未知
Rapid respiratory microbiological point-of-care-testing in primary care: a randomised controlled efficacy trial with internal pilot and qualitative and quantitative investigation of microbial, behavioural and antibiotic mechanisms (the RAPID-TEST RCT)
niversity of Bristol0 个研究点目标入组 514 人开始时间: 2022年11月8日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 514
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38768129/ (added 22/05/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged >=12 months on the day of presentation to primary care.
- •2. Presenting to primary care for the first time in this episode, and within 21 days of illness onset, with a Study Clinician suspected acute respiratory infection. Symptoms may include one or more of:
- •2.1. Sore throat
- •2.2. Runny nose
- •2.3. Earache
- •2.4. Cough
- •2.5. Sputum
- •2.6. Wheeze
- •2.7. Shortness of breath
- •3. Study Clinician diagnoses of an upper or lower RTI such as:
- •3.1. Acute otitis media
- •3.2. Acute sinusitis
- •3.3. Acute pharyngitis or tonsillitis
- •3.4. Sore throat
- •3.5. Acute laryngitis
- •3.6. Acute cough
- •3.7. Acute bronchitis
- •3.8. Chest infection
- •3.9. Acute lower RTI
- •3.10. Infective exacerbation of chronic lung disease e.g. asthma, chronic obstructive pulmonary disease (COPD), emphysema or bronchiectasis
- •4. Study Clinician or patient/parent/carer believes antibiotic treatment is, or may be, necessary (either Study Clinician or patient/parent/carer must answer strongly agree, agree or neither agree nor disagree to the question about beliefs on use of antibiotics to treat this illness).
- •5. Patient/parent/carer willing and able to give informed consent
- •6. Patient/parent/carer willing to have a nasal and throat swab taken, or willing and able to collect, self-take and promptly return the swab to the site
- •7. Study Clinician and patient/parent/carer willing to wait for the POCTRM result before an antibiotic prescribing decision is made
- •8. Laboratory transport pick up for samples expected < 24 hours e.g. sample is expected to be ready prior to final sample collection on a Friday
- •9. Patient/parent/carer willing to complete Trial Diary and for outcome data to be collected from medical record
排除标准
- •1. Patient known to have cystic fibrosis
- •2. Patient requires hospital admission
- •3. Previous participation in the current RAPID-TEST trial
- •4. Participation in another study of RTI < = 6 weeks prior to randomisation
研究者
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