A Comparison Study Between Cefdinir and Amoxicilline/Clavulanate in Patients With Acute Sinusitis and Assessment of Quality of Life (QOL)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improvement in quality of life
研究概览
简要总结
This study is a comparison between two commonly used antibiotics (Cefdinir vs. Amoxicillin/Clavulanate) in patients with acute sinus infection, surveying quality of life. The hypothesis is that the two treatments would be at the least equivalent based on clinical outcome measures of improvement in quality of life.
详细描述
The purpose if this investigation is to evaluate the rate of improvement ub Quality of LIfe (QOL) in two different medications, a 10-day course of Cefdinir 300 mg PO BID versus a 10-day course of Amoxicillin/Clavulanate 1000 mg/62.5 mg XR BID, in the treatment of acute bacterial sinusitis.
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
- Double (Participant, Investigator)
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 and female outpatient adults greater than 18 years old fulfilling the case definition for acute bacterial sinusitis
- •Case definition includes clinical signs and symptoms, radiographic findings and collection of purulent material from the sinus
排除标准
- •Symptoms less than 7 days and more than 3 weeks
- •History of sinus surgery within 3 months
- •History of frequent sinus infections (more than 2 episodes within the last 6 months)
- •History of kidney and liver disease
- •Pregnant and nursing women
- •Pre-existing disease that could predispose to sinus infections (cystic fibrosis or nasal polyps
- •Immunosuppressed patients
- •History of allergy to either drug. Patients with a documented history of allergies to either penicillin or cephalosporins will be excluded.
研究组 & 干预措施
1
cefdinir
干预措施: Cefdinir (drug) (Drug)
2
amoxicillin/clavulanate
干预措施: amoxicillin/clavulanate (Drug)
结局指标
主要结局
Improvement in quality of life
时间窗: At baseline and within 1 week of completing treatment
SNOT 20 questionnaire
时间窗: At baseline and within 1 week of completing treatment
次要结局
- Clinical signs and symptoms alleviated(At baseline and within 1 week of completing treatment)