Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 468
- 试验地点
- 3
- 主要终点
- Length of antibiotic treatment
研究概览
简要总结
The purpose of this study is to evaluate two different treatment strategies in patients admitted to hospital with Community Acquired Pneumonia. The investigators hypothesize treatment according to both procalcitonin (PCT) and C-reactive protein (CRP) will be effective in reducing the length of antibiotic treatment.
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
- •Male and female patients with a diagnosis of CAP and all criteria listed below:
- •Age 18 or above, no upper age limit will be employed.
- •Patients must require hospitalisation.
- •Clinical presentation of an acute illness with one or more of the following symptoms:
- •Temperature ≥ 38.0 ⁰C (100.4°F)
- •Cough (with or without expectoration of sputum)
- •Malaise or fatigue
- •Gastro-intestinal symptoms
- •Rales, rhonchi or wheezing
- •Egophony or bronchial breath sounds
- •New consolidation(s) on the chest radiograph.
- •Written informed consent obtained.
- •(Pre-event) Life expectancy > 30 days
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •(Severe) immunosuppression (e.g. HIV infection, chemotherapy, use of immunosuppressants).
- •Active neoplastic disease.
- •Obstruction pneumonia (e.g. from lung cancer).
- •Aspiration pneumonia.
- •Pneumonia that developed within 8 days after hospital discharge.
- •Unable and/or unlikely to comprehend and/or follow the protocol.
- •Pregnant and/or lactating women.
- •Other infection that requires treatment with antibiotics
研究组 & 干预措施
Common clinical practice
Treatment according to current guidelines. Often a 7 day course of antibiotics. Initial treatment should be broad spectrum antibiotics and can be narrowed down if a specific pathogen is identified.
干预措施: Treatment according to current guidelines (Drug)
CRP-guided treatment
Treatment according to CRP levels. Patients will be started on broad spectrum antibiotics for at least 3 days, treatment can be switched to small-spectrum antibiotics if a specific pathogen is identified. From day 4 to 7 daily blood tests will be performed in order to evaluate whether or not treatment can be discontinued. If treatment is discontinued, no more blood tests will be performed.
干预措施: Discontinuation of treatment according to CRP levels (Drug)
PCT guided treatment
Treatment according to PCT levels. Patients will be started on broad spectrum antibiotics for at least 3 days, treatment can be switched to small-spectrum antibiotics if a specific pathogen is identified. From day 4 to 7 daily blood tests will be performed in order to evaluate whether or not treatment can be discontinued. If treatment is discontinued, no more blood tests will be performed.
干预措施: Discontinuation of treatment according to PCT levels (Drug)
结局指标
主要结局
Length of antibiotic treatment
时间窗: End of the study
次要结局
- Length of stay(End of the study)
- Clinical response(End of the study)
- 30-day mortality(End of the study, periodically by the DSMB)
- Time to clinical stability(End of the study)
- Relapse rate(End of the study)
研究者
W.G.Boersma
MSc, MD, PhD
Medical Center Alkmaar