Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 123
- 主要终点
- Percentage of Participants With Response of Very Convenient or Somewhat Convenient
研究概览
简要总结
The purpose of this study is to compare compliance between patients with Acute Bacterial Sinusitis (ABS) 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 ABS in outpatient clinic practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 nor pregnant or lactating female outpatients, 18 years of age or older.
- •A clinical diagnosis of acute bacterial uncomplicated maxillary sinusitis as demonstrated by presence of the following signs and symptoms for a minimum duration of 7-10 days:
- •Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and
- •Presence of one or more of the following signs:
- •i.purulent nasal discharge ii.purulent drainage in the posterior pharynx iii.purulent discharge from the maxillary sinus orifice
- •A sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis. At least one of the following must be documented in one or both maxillary sinuses on radiologic examination:
- •complete or partial opacification
- •an air/fluid level
- •Two or more of the following:
- •fever, as defined by temperature: >38ºC
- •leukocytosis [White Blood Cell (WBC) >10,000/mm3 or >15% band forms], ECR;
- •nasal congestion and post nasal drainage.
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
Azithromycin SR
Acute Bacterial Maxillary Sinusitis
干预措施: Azithromycin SR (Drug)
Amoxiclav 1000 mg
Acute Bacterial Maxillary Sinusitis
干预措施: Amoxiclav 1000 mg (Drug)
结局指标
主要结局
Percentage of Participants With Response of Very Convenient or Somewhat Convenient
时间窗: Day 11
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 Prescribed Treatment Regimen(Day 11)
- Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen(Day 11)