Non-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 30
- 主要终点
- Percentage of Participants With Response of Very Convenient or Somewhat Convenient
研究概览
简要总结
To compare compliance between patients with CAP treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of CAP in outpatient clinic practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or not pregnant or lactating females, 18 years of age or older, for whom oral antibacterial therapy is indicated with clinically evidence of Diagnosis of pneumonia, based on usual clinical practice:
- •Physical examination and auscultatory findings (dullness on percussion, bronchial breath sounds, egophony, dry or fine most rales).
- •Body temperature >38 degrees C.
排除标准
- •Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin.
- •Amoxiclav according to LPDs, pregnant or lactating women.
研究组 & 干预措施
Z-max treated group
Patients with Community-Acquired Pneumonia
干预措施: Azithromycin SR (Drug)
Amoxiclav treated group
Patients with Community-Acquired Pneumonia
干预措施: Amoxiclav (Drug)
结局指标
主要结局
Percentage of Participants With Response of Very Convenient or Somewhat Convenient
时间窗: Days 11-12
Participant reported outcome questionnaire was the assessment of participant's convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered 'very convenient' or 'somewhat convenient' and 0 if participant answered 'not convenient' or 'not at all convenient'.
次要结局
- Percent Compliance With the Prescribed Treatment Regimen(Days 11-12)
- Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen(Days 11-12)