NCT00111644已完成2 期
A Randomized, Double-blind Study of the Effect of Beta-lactam on Treatment Response in Patients Hospitalized With Bacterial Pneumonia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 302
- 主要终点
- Clinical cure rate\n\n
研究概览
简要总结
This study will assess the efficacy and safety of intravenous beta-lactam, in comparison with ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by Legionella. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
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
- Double (Participant, Investigator)
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 or female patients at least 18 years of age;
- •hospitalization with community-acquired pneumonia or development of pneumonia within 48 hours of being hospitalized for another reason;
- •new or increased productive cough;
- •chest pain, shortness of breath, or rapid breathing.
排除标准
- •requiring intubation or ventilation;
- •nursing home or extended care within 60 days before study;
- •concomitant bacterial infection requiring antibiotics;
- •long-term immunosuppressive therapy.
研究组 & 干预措施
1
Experimental
干预措施: beta-lactam (Drug)
2
Experimental
干预措施: beta-lactam (Drug)
3
Active Comparator
干预措施: Ceftriaxone (Drug)
结局指标
主要结局
Clinical cure rate\n\n
时间窗: End of study visit (7-10 days after end of treatment)
次要结局
- Adverse events, vital signs, laboratory parameters\n(Throughout study)
研究者
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