A Randomized, Multicenter, Open Label Trial Comparing Intravenous Zithromax® (Azithromycin) Plus Intravenous Rocephin® (Ceftriaxone) Followed By Oral Zithromax® (Azithromycin) With Intravenous Levaquin® (Levofloxacin) Followed By Oral Levaquin® (Levofloxacin) For The Treatment Of Moderate To Severely Ill Hospitalized Subjects With Community-Acquired Pneumonia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Efficacy of sequential therapy with IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® (levofloxacin) followed by oral Levaquin® in the treatment of moderate to severely ill subjects with community-acquired pneumonia.
研究概览
简要总结
A trial in which patients over 18 years of age who are hospitalized with community acquired pneumonia and are otherwise eligible for entry into the study are randomly selected to receive one of two treatment regimens. After written informed consent is obtained, patients will receive one of the following two treatment regimens: 1) intravenous administration of azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous administration of levofloxacin followed by levofloxacin tablets. At least four study visits are normally conducted up to approximately one month after starting therapy. The objective of this study is to compare the safety and efficacy of the two treatment regimens.
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
- •Patient must be 18 years or older.
- •Patient must be hospitalized and require intravenous therapy for treatment of pneumonia.
- •Patient must have pneumonia as documented by relevant signs and symptoms and a positive chest X-ray.
- •Patients cannot have certain underlying diseases or conditions as defined in the study protocol.
排除标准
- •Pregnant women, nursing mothers, or women of childbearing potential not practicing adequate contraception.
- •Known or suspected hypersensitivity or intolerance to any quinolone, penicillin, cephalosporin, or macrolide antibiotic.
- •Treatment with any systemic antibiotic for 24 hours or longer within 72 hours prior to the baseline visit.
- •Subjects with clinically significant renal dysfunction.
- •Subjects with clinically significant hepatic dysfunction.
- •Subjects with clinically significant cardiovascular disorders.
研究组 & 干预措施
Azithromycin plus ceftriaxone group (AZY+CEF group)
IV azithromycin (500 mg once daily) plus ceftriaxone (1 gram once daily) for 2 to 5 days followed by oral azithromycin (2 x 250 mg once daily) to complete a total of 7 to 10 days of therapy
干预措施: IV azithromycin (Drug)
Azithromycin plus ceftriaxone group (AZY+CEF group)
IV azithromycin (500 mg once daily) plus ceftriaxone (1 gram once daily) for 2 to 5 days followed by oral azithromycin (2 x 250 mg once daily) to complete a total of 7 to 10 days of therapy
干预措施: ceftriaxone (Drug)
Azithromycin plus ceftriaxone group (AZY+CEF group)
IV azithromycin (500 mg once daily) plus ceftriaxone (1 gram once daily) for 2 to 5 days followed by oral azithromycin (2 x 250 mg once daily) to complete a total of 7 to 10 days of therapy
干预措施: oral azithromycin (Drug)
Levofloxacin group (LEV group)
IV levofloxacin (500 mg once daily) for a minimum of 2 days followed by oral levofloxacin (500 mg once daily) to complete a total of 7 to 14 days of therapy.
干预措施: IV levofloxacin (Drug)
Levofloxacin group (LEV group)
IV levofloxacin (500 mg once daily) for a minimum of 2 days followed by oral levofloxacin (500 mg once daily) to complete a total of 7 to 14 days of therapy.
干预措施: oral levofloxacin (Drug)
结局指标
主要结局
Efficacy of sequential therapy with IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® (levofloxacin) followed by oral Levaquin® in the treatment of moderate to severely ill subjects with community-acquired pneumonia.
时间窗: Duration of trial
次要结局
- Safety and toleration of IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® followed by oral Levaquin®, and to compare the bacteriological response rates in subjects with a baseline pathogen.(Duration of trial)