NCT00643734已完成3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults
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
- 468
- 试验地点
- 1
- 主要终点
- sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
研究概览
简要总结
The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens.
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 with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.
排除标准
- •Key exclusion criteria were treatment with any systemic antibiotic of greater than one dose or one combination dose within the previous 7 days, previously diagnosed conditions which tend to mimic or complicate the course and the evaluation of the evaluation process (e.g., bronchiectasis, lung abscess or empyema, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia), hospitalization in the previous 14 days or infection acquired in the hospital, and residents of a long-term care facility.
研究组 & 干预措施
1
Experimental
干预措施: azithromycin sustained release (Drug)
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 (cure or failure) in the Clinical Per Protocol population
时间窗: Test of Cure (TOC) visit (Days 14-21)
次要结局
- laboratory abnormalities(Baseline and TOC visit)
- sponsor assessment of clinical response (cure or failure) in the remaining study populations(EOT visit and TOC visit)
- sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population(EOT visit and TOC visit)
- investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population(TOC visit)
- sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population(Long-Term Follow-Up (LTFU) visit (Days 28-35))
- bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population(TOC visit)
- summary of baseline susceptibilities(Study endpoint)
- adverse events(Continuous)
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 Acute Symptoms of Chronic BronchitisBronchitis, ChronicNCT00644449Pfizer551
已完成
3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in AdultsMaxillary SinusitisNCT00643409Pfizer541
已完成
3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and AdultsTonsillitisPharyngitisNCT00644293Pfizer598
已完成
不适用
An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium Avium-Intracellulare Complex Infection (MAC) in Patients With Acquired Immune Deficiency Syndrome (AIDS)Mycobacterium Avium-Intracellulare InfectionHIV InfectionsNCT00002090Pfizer