The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark: an Open-Label, Pragmatic, Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Treatment failure at day 30
研究概览
简要总结
The aim of this randomised controlled trial is to identify the optimal treatment duration with phenoxymethylpenicillin for community-acquired pneumonia diagnosed in general practice.
Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.
Consenting patients who meet all the eligibility criteria will be randomised (1:1:1:1:1) to either three, four, five, six or seven days of treatment with phenoxymethylpenicillin 1.2 MIE four times daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnoea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.
排除标准
- •Need for immediate hospitalisation at the time of diagnosis.
- •Known allergy to beta-lactam antibiotics.
- •Any coinfection necessitating antibiotic treatment.
- •Use of systemic antibiotics or antivirals within the last month.
- •Pre-existing lung disease (e.g., chronic obstructive pulmonary disease, bronchiectasis, asthma, lung cancer).
- •Known immunosuppression (i.e., long term treatment with corticosteroid, chemotherapy, or immune disorder).
- •Pregnant or lactating.
- •Patients not capable of consenting and/or patients deemed non-suitable for participation by the healthcare professional.
研究组 & 干预措施
3 days
3 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.
干预措施: Phenoxymethylpenicillin 1.2 MIE 4 times daily (Drug)
4 days
4 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.
干预措施: Phenoxymethylpenicillin 1.2 MIE 4 times daily (Drug)
5 days
5 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.
干预措施: Phenoxymethylpenicillin 1.2 MIE 4 times daily (Drug)
6 days
6 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.
干预措施: Phenoxymethylpenicillin 1.2 MIE 4 times daily (Drug)
7 days
7 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.
干预措施: Phenoxymethylpenicillin 1.2 MIE 4 times daily (Drug)
结局指标
主要结局
Treatment failure at day 30
时间窗: From randomisation to day 30
Treatment failure is defined as any hospitalisation OR change in the antibiotic strategy (i.e., prolongation of the duration, change in antibiotic type, new antibiotic prescription) due to symptoms of acute respiratory tract infection - between randomisation and day 30.
次要结局
- The Acute Respiratory Tract Infection Questionnaire (ARTIQ) score(At randomisation day and day 8)
- Clinical recovery at day 8(From randomisation to day 8)
- Change in type of antibiotic(From randomisation to day 30)
- Relapse of acute Lower Respiratory Tract Infection (LRTI)(From randomisation to day 30)
- Hospitalisation(From randomisation to day 30)
- Prolonged antibiotic treatment(From randomisation to day 30)
- Reconsultation(From randomisation to day 30)
- New prescriptions within 30 days(From randomisation to day 30)
- Treatment adherence(From randomisation to day 8)
- Mortality(From randomisation to day 30)
- Adverse events(From randomisation to day 30)