NCT00644553已完成3 期
A Phase IIIB/IV Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets vs. Amoxicillin-Clavulanate for the Treatment of Subjects With Acute Bacterial Sinusitis
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
- Abbott
- 入组人数
- 437
- 主要终点
- Clinical Response
研究概览
简要总结
To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects with Acute Bacterial Sinusitis (ABS).
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
- Single (Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The female must be non-lactating and at no risk for pregnancy.
- •Subject must have a diagnosis of ABS. The diagnosis must be based on the following:
- •A sinus radiograph (Water's view) or CT scan with evidence of maxillary opacification or
- •Air/fluid levels purulent discharge from the nose
- •At least two of the following additional signs and symptoms lasting longer than seven days prior to and no longer than 28 days before Evaluation
- •A pre-treatment sample from a sinus puncture or
- •Middle meatus endoscopy must be obtained for bacterial aerobic culture
- •Susceptibility testing (applicable only for selected investigative sites).
- •Subject must be a suitable candidate for oral antibiotic therapy and able to swallow tablets intact.
排除标准
- •A medical history of hypersensitivity or allergic reactions to clarithromycin, erythromycin, amoxicillin/clavulanate, any penicillin or any of the macrolide antibiotics.
- •History of amoxicillin-clavulanate associated cholestatic jaundicehepatic dysfunction.
- •Females who are pregnant or lactating.
- •Subject has either of the following:
- •Chronic sinusitis (signs and symptoms lasting longer than 28 days immediately prior to Evaluation 1)
- •Significant anatomical abnormalities of the sinuses any other infection or
- •Condition which necessitates use of a concomitant systemic antibiotic.
- •Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, psychiatric or endocrine disease, malignancy, or other abnormality (other than the disease being studied).
- •Any underlying condition/disease, that would be likely to interfere with the completion of the course of study drug therapy or follow-up.
- •Known significant renal or hepatic impairment (or disease).
- •Subject who has taken: a systemic antibiotic within 2 weeks before study drug administration or a long-acting injectable antibiotic (e.g., penicillin G benzathine) within 4 weeks before study drug administration.
- •Immunocompromised subjects (e.g., neutropenic subjects).
- •Subjects with known HIV infection.
- •Treatment with any other investigational drug within 4 weeks prior to study drug administration.
研究组 & 干预措施
A
Active Comparator
干预措施: Clarithromycin (Drug)
B
Active Comparator
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Clinical Response
时间窗: 33 days
次要结局
- Radiographic Response(33 days)
研究者
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