Clinical Application of PCR-based Diagnosis of Community-onset Viral Respiratory Infections.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 406
- 试验地点
- 2
- 主要终点
- Antibiotic treatment prescriped at initial visit
研究概览
简要总结
Viral respiratory infections are common worldwide. It has been suggested that nucleic acid amplification tests, enabling a rapid etiologic diagnosis, may be useful in reducing antibiotic prescriptions rates. The objective of this study was to evaluate if access to a multiplex real-time PCR method would have an impact on antibiotic prescriptions for acute respiratory tract infections (ARTIs), in primary care. Adult patients with respiratory tract infections will be prospectively included. Nasopharyngeal and throat swabs will be analyzed with a multiplex real-time PCR method, targeting 13 viruses and two bacteria. Samples will be collected during the winter season (October-April). Patients will be open-label randomised to receive a rapid result (the following day) or a delayed result (after 10+/-2 days). The investigators are planning to include approximately 400 patients. Prescription of antibiotics will be measured at initial visit as well as at a follow-up visit 10+/-2 days later. Primary endpoint is antibiotic prescription in the acute phase (initial visit) and secondary endpoint antibiotic treatment (ongoing or initiated) at follow-up visit. The hypohesis is that access to a method with the ability of providing a rapid etiologic diagnosis of respiratory infections will affect the use of antibiotics in outpatient care of adult patients with ARTI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Age 18 years or older
- •At least two of the following symptoms: coryza, congestion, sneezing, sore throat, odynophagi, cough, chest pain, shortness of breath or fever for which teh physician found no other explanation.
- •Symptom duration of less than 14 days
排除标准
- •>14 days of symptoms
- •confirmed bacterial infection
- •Hospital acquired infection (>3days in hospital)
结局指标
主要结局
Antibiotic treatment prescriped at initial visit
时间窗: Within 2 days of initial visit
Antibiotic prescriptions are measured as an outcome of the diagnostic procedure tested.
次要结局
- Antibiotic treatment prescribed or reported at follow-up visit(10+/-2 days)
