The Effect of Focused Lung Ultrasonography on Antibiotic Prescribing in Patients With Acute Lower Respiratory Tract Infections in Danish General Practice: A Pragmatic Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 391
- 试验地点
- 2
- 主要终点
- Antibiotics prescribed at index consultation
研究概览
简要总结
The goal of this randomised controlled trial is to determine if adults presenting with symptoms of an acute lower respiratory tract infection in general practice where the general practitioner suspects CAP, who have FLUS performed as an addition to usual care, have antibiotics prescribed less frequent compared to those given usual care only.
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
- Double (Investigator, Outcomes Assessor)
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.
- •Acute cough (< 21 days).
- •At least one other symptom of acute lower respiratory tract infection (LRTI).
- •The general practitioner suspects a bacterial community-acquired pneumonia.
排除标准
- •Previous antibiotic treatment for the current episode of acute LRTI.
- •The patient is not listed with the general practitioner (no medical record available).
- •The patient is not capable of understanding and signing informed consent.
- •The patient does not wish to participate in the study.
结局指标
主要结局
Antibiotics prescribed at index consultation
时间窗: Day 0
The primary outcome is the proportion of participants with antibiotics prescribed at index consultation (day 0) reported by the GP at index consultation. We will assess the effect of adding FLUS to usual care on antibiotics prescribed at index consultation by investigating if there is a difference between groups in the proportion of participants with antibiotics prescribed at index consultation..
次要结局
- Satisfaction with the index consultation(Day 0)
- Antibiotics prescribed during follow-up(Up until day 28)
- Complications(Up until day 28.)
- Days with symptoms being a "moderate problem" or worse(From day 0 until participants have scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.)
- Admission to hospital(Up until day 28.)
- Spontaneously reported unintended events(Up until day 60.)
- Daily total LRTI symptom-score(From day 0 until participants have scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.)
- Days signed in sick/cancelled work-related activities(From day 0 until the participant has scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.)
- Antibiotics prescribed as delayed antibiotic prescription(Day 0)
- Re-consultations(Up until day 28.)
- Types of other imaging performed(Up until day 28.)
- Referred with suspicion of cancer(Up until day 60.)
- Diagnoses of cancer(Up until day 60.)
- Other imaging than FLUS performed(Up until day 28.)
- Mortality(Up until day 28 and 60.)
研究者
Julie Jepsen Strøm
MD
Aalborg University