NCT00717561已完成3 期
A National, Prospective, Randomized, Open Label Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin vs IV Ceftriaxone + IV Azithromycin Followed by PO Amoxicilline/Clavulanate and PO Clarithromycin in Subjects With Community-acquired Pneumonia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 60
- 主要终点
- Clinical response 20 days after completion of study treatment (Test-of-Cure visit)
研究概览
简要总结
The purpose of this study is to assess if a therapy with oral and intravenous moxifloxacin is as effective as a therapy with intravenous ceftriaxone + intravenous azithromycin followed by oral amoxicilline/clavulanate and oral clarithromycin in the treatment of community-acquired 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
- •Hospitalized non-ICU patients (age, >= 18 years)
- •Clinical signs and symptoms of CAP, with PSI score IV or V
- •Radiologically confirmed evidence of a new and/or progressive infiltrate(s)
- •Requirement for initial parenteral therapy
- •At least 2 of the following conditions:
- •Productive or non productive cough with or without purulent or mucosus or mucopurulent sputum
- •Dyspnea and/or tachypnea (respiratory rate of > 20 breaths/min)
- •Rigors and/or chills
- •Pleuritic chest pain
- •Auscultatory findings of rales and/or crackles on pulmonary examination and/or evidence of pulmonary consolidation
- •Fever (an oral temperature of >= 38 °C, a rectal temperature of >= 39 °C, or a tympanic temperature of >= 38.5 °C) or hypothermia (rectal or core temperature of < 35 °C), and a WBC count of >= 10,000 cells/mm3 or >= 15% immature neutrophils bands; regardless of peripheral WBC count) or leukopenia (total WBC count of < 4500 cells/mm3)
- •Written informed consent
排除标准
- •PSI Class I-III and V with need for ICU admission
- •Hospitalization for > 48 hours before developing pneumonia, or discharge from hospital < 30 days prior. Note: patients currently residing in residential long-term facilities can be enrolled in the study
研究组 & 干预措施
Arm 1
Experimental
干预措施: Avelox (Moxifloxacin, BAY12-8039) (Drug)
Arm 2
Active Comparator
干预措施: Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin (Drug)
结局指标
主要结局
Clinical response 20 days after completion of study treatment (Test-of-Cure visit)
时间窗: 20 days after last dose of study drug (TOC Visit)
次要结局
- Bacteriological response at TOC(20 days after last dose of study drug)
- Clinical and bacteriological response at the end of treatment(Day 7-14 after first dose of study drug)
- Mortality attributable to pneumonia at the Test-of-Cure visit(20 days after last dose of study drug)
- Clinical and bacteriological response on treatment Day 3-5 (if the day of switch is different from Day 3, 4 or 5)(Day 3-5)
- Clinical and bacteriological response on the day of switch from IV to oral therapy(Day of switch from IV to oral therapy)
研究者
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