Oral Versus Intravenous Antibiotics for the Treatment of Pleural Space Infection: a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Enrollment feasibility
研究概览
简要总结
We aim to conduct a pilot trial assessing oral versus intravenous therapy for pleural space infections.
详细描述
Pleural space infections are a frequent clinical problem resulting in significant morbidity and mortality as well as healthcare cost. Despite the increasing burden of disease, there are no clinical trials evaluating antibiotic therapy in pleural space infections. Hence, British and American guidelines are only able to provide weak and vague recommendations regarding duration, type or route (intravenous or oral) of antibiotic therapy. Our goal is to determine whether oral (PO) therapy is non-inferior to intravenous (IV) therapy thereby decreasing risks of IV catheter related infections, vein thrombosis and health care costs. Similar studies have been successfully conducted in the setting of bone/joint infections and endocarditis and showed non-inferiority of oral antibiotics. However, in order to help ensure that the randomized trial is of good quality, it is important to assess the feasibility of such a trial by first conducting a pilot study. The goal of this pilot trial is to assess the feasibility of the proposed study design.
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
- •Must meet our study definition of pleural space infection
- •Age > or = 18 years old
- •Life expectancy > 1 year
- •Received intravenous or oral antibiotics for = or < 7 d from surgical intervention or received a total of = or < 7 d of antibiotics if no intervention performed
排除标准
- •S. aureus bacteremia or endocarditis in the last 1 month
- •Another concomitant infection requiring prolonged IV antibiotics
- •Esophageal rupture or malignant pleural effusion
- •Septic shock or systemic features requiring IV antibiotics
- •Mycobacterial, fungal or parasitic pleural space infection
- •No oral antibiotic options available
- •Unlikely to comply with therapy
研究组 & 干预措施
Intravenous therapy
Intravenous antibiotics administered for pleural space infection
干预措施: Antibiotics (Drug)
Oral therapy
Oral antibiotics administered for pleural space infection
干预措施: Antibiotics (Drug)
结局指标
主要结局
Enrollment feasibility
时间窗: 3 months
Proportion of eligible participants screened that are randomized within 5 days of initial intravenous antibiotic exposure
Completion feasibility
时间窗: 3 months
Proportion of participants with follow-up at 4 weeks either through a clinic visit or phone call
次要结局
- Antibiotic duration(3 months)
- Hospitalization duration(3 months)
- Stopping antibiotics(3 months)
- IV line complications(3 months)
- C. difficile(3 months)
- Mortality(3 months)
- Treatment failure(3 months)
研究者
Phillipe El-Helou
Principal Investigator
St. Joseph's Healthcare Hamilton