EUCTR2014-003137-25-ES进行中（未招募）不适用
Optimal duration of antibiotic treatment in patients with complicated parapneumonic pleural effusions or empyema: a randomized clinical trial - ODAPE
José Manuel Porcel Pérez Hospital Arnau de Vilanova de Lleida Servicio Medicina Interna0 个研究点开始时间: 2014年10月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-18 years of age or older
- •-Clinical evidence of CPPE; defined as a neutrophilic exudated in the context of
- •a community acquired pneumonia; or empyema, defined as the presence of pus
- •in pleural cavity. A CPPE required, according to the attending physician, a chest
- •tube drainage. Most patients will satisfy the following criteria: 1) pleural fluid
- •pH < 7.2 or pleural fluid glucose < 60 mg/dL, 2) Gram-positive or pleural fluid
- •positive culture or 3) pleural effusion that occupy 50% or more of a hemithorax
- •in a thorax radiography or it is loculated in an image exploration (radiography,
- •ultrasound or computed tomography).
- •-Clinical stability 2 weeks after diagnosis and antibiotic therapy beginning,
- •defined as: 1) absence of fever (temperature < 37.8oC), heart rate < 100 bpm,
- •breath rate < 24 bpm and systolic blood pressure > 90 mmHg. 2) Thorax
- •radiography without pleural effusion or that occupy less than 20% of the
- •hemithorax without chest tube in that moment. 3) Serum C-reactive protein drop
- •of at least 50% from the diagnosis.
- •-Capable of giving written informed consent.
- •3. Clinical stability at 2 weeks of diagnosis and treatment with amoxicillin-clavulanate of DPPC or empyema. This must meet three requirements: 1) in the past 48 hours: T ª <37.8 ° C, HR <100 bpm FR <24 rpm and SBP> 90 mmHg, 2) pleural effusion on chest radiograph occupying less than 20% of the hemithorax with pleural drainage and retired at the time, and 3) decrease in serum C-reactive protein of at least 50% from diagnosis.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •-Pregnant women
- •-Allergy for amoxicillin clavulanate
- •-Immunosuppression: neutropenia, HIV infection, haematological neoplasms,
- •solid-organ transplantation or steroids or immunosuppressive treatments.
- •-Tuberculous pleural infection
- •-Nosocomial-, nursinghome- or healthcare-associated pneumonia.
- •-Infection due to microorganisms that require alternative therapeutic regimens.
- •-Life expectancy less than three months due to other causes.7. Expected survival less than 3 months from other causes
- •8. Patients who did not sign the informed consent
研究者
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