NCT00643409已完成3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Bacterial Maxillary Sinusitis in Adults Undergoing Diagnostic Sinus Aspiration
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
- Pfizer
- 入组人数
- 541
- 试验地点
- 1
- 主要终点
- sponsor assessment of clinical response for the Clinical per Protocol population
研究概览
简要总结
The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.
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
- •Patients were included if they had a clinical diagnosis of acute bacterial maxillary sinusitis as demonstrated by presence of the cardinal signs and symptoms for a minimum duration of 7 days, a sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage.
排除标准
- •Patients were excluded if they were treated with any systemic antibiotic within 7 days prior to enrollment, had symptoms lasting for longer than 28 days, had 4 or more episodes of acute sinusitis within the preceding 12 months, had nasal or sinus surgery within 3 months prior (except for a diagnostic procedure), or complicated or nosocomial sinusitis.
研究组 & 干预措施
1
Experimental
干预措施: placebo (Other)
2
Experimental
干预措施: levofloxacin (Drug)
2
Experimental
干预措施: placebo (Other)
结局指标
主要结局
sponsor assessment of clinical response for the Clinical per Protocol population
时间窗: Test of Cure (TOC) visit (Day 17-24)
次要结局
- sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population(EOT visit and TOC visit)
- investigator assessment of clinical response for the Clinical per Protocol population(TOC visit)
- bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population(TOC visit)
- summary of baseline susceptibilities(Study endpoint)
- adverse events(Continuous)
- laboratory abnormalities(during and post-treatment)
- sponsor assessment of clinical response for the Clinical per Protocol population(End of Treatment (EOT) visit (Day 11-13))
- sponsor assessment of clinical response for the remaining study populations(EOT visit and TOC visit)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult PatientsPneumoniaNCT00643227Pfizer504
已完成
3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult PatientsPneumoniaNCT00643734Pfizer468
已完成
3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic BronchitisBronchitis, ChronicNCT00644449Pfizer551
终止
2 期
Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast AsiaMalaria, FalciparumNCT00084240Pfizer32
已完成
3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In ChildrenTonsillitisNCT00643149Pfizer693