NCT00493038终止4 期
Prospective, Multicenter, Randomized, Double Blind, Parallel Arm Study to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg OD for 7 Days Versus a Standard Antibiotic Therapy for 10 Days in the Treatment of Acute Bacterial Rhino Sinusitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 293
- 主要终点
- Number of Participants With Response (Per-protocol Population)
研究概览
简要总结
This is a clinical study organized to collect clinical data to better define the activity of some antimicrobials already marketed in Italy and in the rest of the world for the treatment of acute bacterial rhinosinusitis
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
- Triple (Participant, Care Provider, 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
- •Age >= 18 years
- •Clinical diagnosis of acute rhinosinusitis with signs and symptoms present for >/= 5-7 days but < 28 days
- •Clinical diagnosis will be confirmed by nasal endoscopic examination
排除标准
- •History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subject with history of sinus surgery may be included; subjects with recurrent acute sinusitis may be included)
- •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
- •Known immunodeficiency diseases including, but not limited to: neutropenia (neutrophil count < 1000/mm3), human immunodeficiency virus (HIV) infection (Cluster of differentiation 4 (CD4)+ T-cell count of < 200/mm3). Note: HIV testing is not required
- •Received systemic antibacterial therapy likely to be effective in the treatment of acute bacterial sinusitis for more than 24 hours within 5/6 days of enrollment
- •Requirement for concomitant systemic antibacterial therapy with agents other than those specified in this protocol
- •Currently receiving topical nasal corticosteroids, unless they have been on a stable dose for > 4 weeks prior to enrollment
- •Requirement for concomitant therapy with systemic corticosteroids
- •Pregnant or breast feeding
- •Of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable barrier method of contraception
- •Received an investigational drug in the past 30 days
- •Previously enrolled in this study
- •Unable to take oral medication
- •History of allergy to quinolone antibiotics or related compounds and beta-lactams
- •History of tendinopathy associated with quinolones
- •Known to have congenital or sporadic syndromes of QT interval corrected for rate (QTc) prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine)
- •Uncorrected hypokalemia
- •End stage liver cirrhosis (class Child-Pugh C)
- •Severe renal impairment requiring dialysis
- •Diagnosis of rapidly fatal illness with a life expectancy of less than 6 months
研究组 & 干预措施
Moxifloxacin (Avelox, BAY12-8039)
Experimental
Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID)for 10 days
干预措施: Moxifloxacin (Avelox, BAY12-8039) (Drug)
Amoxicillin/Clavulanate
Active Comparator
Amoxicillin/clavulanate 1000 mg tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
干预措施: Amoxicillin/Clavulanate (Drug)
结局指标
主要结局
Number of Participants With Response (Per-protocol Population)
时间窗: At 'Test-of-Cure', Day 1-3 after treatment
Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 1-3 days after treatment was assessed by the investigator as "clinical cure"
次要结局
- Number of Participants With Response (Intent-to-treat Population)(At 'Test-of-Cure', Day 1-3 after treatment)
- Number of Participants With Response (Per-protocol Population)(End of Follow-up, Day 24-30 after treatment)
- Number of Participants With Response (Microbiologically Valid Patients)(End of Follow-up, Day 24-30 after treatment)
研究者
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