Prospective, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg QD for 5 Days Versus Placebo in the Treatment of Acute Bacterial Sinusitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 374
- 主要终点
- Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of acute bacterial sinusitis, therefore in this study Avelox is considered an investigational drug. In this study Avelox will be compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects must meet all the following criteria at the time of enrollment:
- •Age >/= 18 years
- •Clinical diagnosis of acute bacterial sinusitis with signs and symptoms present for = 7 days but < 28 days as defined by A), radiographic, and B) clinical criteria, as follows:
- •Radiographic Criteria: The presence of one or more of the following on a radiographic paranasal sinus film (Waters' view): - Evidence of air-fluid levels - Opacification
- •Clinical Criteria: The presence of two major symptoms, or the presence of at least one major and one minor symptom as defined in the list below:
- •Major symptoms: - Purulent anterior or posterior nasal discharge - Unilateral facial pain or malar tenderness
- •Minor symptoms: - Frontal headache - Fever (oral = 38.0°C/100.4°F, tympanic = 38.5°C/101.2°F, axillary = 37.5°C/99.5°F) - Culture material obtained by sinus puncture; the aspirated specimen sent for Gram stain, quantitative culture and susceptibility testing prior to initiation of antimicrobial therapy
排除标准
- •Subjects with one or more of the following criteria will not be eligible for this study:
- •History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subjects with recurrent acute sinusitis will be included)
- •History of sinus surgery (antral sinus puncture is not considered as a surgery)
- •Any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
- •Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses
研究组 & 干预措施
Moxifloxacin 400 mg
Moxifloxacin 400mg once daily for 5 days
干预措施: Moxifloxacin (Avelox, BAY12-8039) (Drug)
Placebo
Matching placebo for 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))
时间窗: At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment
The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.
次要结局
- Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach(Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment))
- Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach(Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment))
- Percentage of Subjects With Clinical Improvement During Therapy(Day 3 of treatment)
- Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up(Day 12 to 26 after end of treatment)