NCT00429975终止4 期
Comparison Between Ceftriaxone and Levofloxacin on Cytokine Expression Over Time in Severe Pneumococcal Pneumonia
Hospital Mutua de Terrassa2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2004年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion
研究概览
简要总结
The purpose of this study is to compare levofloxacin vs ceftriaxone impact on the cytokine production in patients with pneumococcal pneumonia.
详细描述
Bacterial alveolar invasion is followed by a compartmentalized inflammatory response. Data suggest that some antimicrobials may induce a differential release of cytokines, with the potential of either accelerating or down regulating cytokine production.
The aim of our study was to compare the effects of ceftriaxone compared with levofloxacin on cytokine systemic concentrations in patients with pneumococcal pneumonia.
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
- •patients with an acute febrile respiratory illness accompanied by a new radiographic infiltrate consistent with this diagnosis.
- •and with a confirmed pneumococcal aetiology
排除标准
- •age < 18 years,
- •pneumonia distal to endobronchial obstruction,
- •pulmonary tuberculosis,
- •bronchiectasis,
- •known allergy to B-lactams or fluoroquinolones,
- •underlying systemic autoimmune disease
- •immunocompromised states including patients on maintenance oral corticosteroids, HIV infection,
- •pregnancy,
- •patients that received antimicrobial therapy in the 15 days preceding the current episode and those who had received fluoroquinolones in the last month, or non steroidal anti-inflammatory therapy in the last two weeks.
- •Patients with renal failure (serum creatinine > 2 mg / dL),
- •and patients with a documented pneumococcal pneumonia in the previous 4 weeks
结局指标
主要结局
Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion
次要结局
- the relationship between cytokine expression, clinical variables and severity of disease.
研究者
研究点 (2)
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