NCT00538018已完成4 期
Telithromycin, Treating Adult Outpatients With Mild to Moderate Community-acquired Pneumonia (CAP) in High Bacterial Resistance Areas
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 978
- 主要终点
- To compare the effect of telithromycin versus "usual care" on the total symptoms score of pneumonia and on health outcomes, in CAP adult outpatients at the end of therapy visit.
研究概览
简要总结
Demonstrate efficacy of telithromycin over single-agent oral antibiotics usually prescribed by local guidelines ("usual care") for treating adult outpatients with mild to moderate community-acquired pneumonia (CAP) in high bacterial resistance areas.
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
- •Adult outpatients with mild to moderate CAP. Diagnosis of CAP was based on the presence of fever and/or hyperleucocytosis and the new and sudden onset of at least two clinical signs and symptoms of pneumonia (cough, dyspnea or tachypnea, chills, pleuritic chest pain, purulent sputum or change in sputum character, auscultatory findings). Clinical diagnosis of CAP had to be confirmed by chest X-ray findings (e.g. presence of presumably new infiltrate). Specimens for microbiological documentation had to be collected within 24 hours prior to enrollment.
排除标准
- •Subjects requiring parenteral antibiotic treatment.
- •Subjects with severe CAP requiring hospitalization. The CAP was to be considered as severe in the presence of any of the following conditions:
- •chest X-ray showing a multilobar consolidation (> 1 lobe)3 and/ or an increase in the size of the opacity by greater than or = to 50% within 48 hours of the current evaluation
- •altered mental status (disorientation to person, place or time that is not known to be chronic, lethargy, stupor or coma)
- •total peripheral white blood cell count < 4,000/mm3
- •requirement for mechanical ventilation
- •requirement for vasopressors
- •acute renal failure
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
To compare the effect of telithromycin versus "usual care" on the total symptoms score of pneumonia and on health outcomes, in CAP adult outpatients at the end of therapy visit.
时间窗: (Days 8-11)
次要结局
- For health outcomes at the test of cure visit; e.g. additional LRTI-related antibiotic use, LRTI related hospitalization with length of stay and LRTI related office visit/emergency room visit.((Days 17-21))
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