The Usefulness of Point-of-care-testing for C-reactive Protein in Lower Respiratory Tract Infection or Acute Cough
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 2
- 主要终点
- the antibiotic prescribing rate
研究概览
简要总结
The aim of this study is to evaluate the usefulness in Russian general practice of C-reactive protein testing in patients with acute cough or lower respiratory tract infections.
In addition to studying the effect of C-reactive protein testing on the prescription of antibiotics, the purpose is to find out whether the frequency of referral to radiography could be reduced.
详细描述
Eighteen general practitioners, from both urban and rural offices, were randomised into intervention and control groups. All registrations were made by general practitioners in their offices.
The case report form was similar to that used in the GRACE study (Genomics to combat Resistance against Antibiotics in Community-acquired lower respiratory tract infections in Europe (www.grace-lrti.org) describing symptoms, findings, and treatment in lower respiratory tract infections.
- The clinical examination included a chest examination and the axillary temperature.
- After the clinical examination, the general practitioners recorded their provisional diagnosis.
- Chest radiography was accessible for all patients.
The C-reactive protein test was performed in the intervention group at both the first and second consultations. The Afinion test system was used, which provides results within 5 minutes and before treatment was determined. This test is based on solid-phase sandwich immunometric analysis.
General practitioners could prescribe any treatment, including antibiotics and other drugs for the cough and additional medication if deemed necessary.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with lower respiratory tract infections/acute cough (including acute bronchitis, pneumonia, and infectious exacerbations of chronic obstructive pulmonary disease or asthma),
- •age 18 years or older,
- •an illness of less than 28 days duration,
- •first consultation for the illness episode,
- •being seen in a physician's office,
- •written consent to participate.
排除标准
- •an inability to fill out study documentation,
- •being previously included in the study,
- •immunocompromised status (HIV patients, immunosuppressive treatment),
- •ongoing treatment with oral corticosteroids
研究组 & 干预措施
C-reactive protein test
The C-reactive protein test was performed in the intervention group at both the first and second consultations.
The Afinion test system (Axis Shield) was used, which provides results within 5 minutes and before treatment was determined. This test is based on solid-phase sandwich immunometric analysis. The measurement range in whole blood samples is 8-200 mg/L.
干预措施: C-reactive protein test (Device)
结局指标
主要结局
the antibiotic prescribing rate
时间窗: within the first 2 weeks after first consultation
次要结局
- referral to radiography(within the first 2 weeks after first consultation)