NCT00643227已完成3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Clarithromycin Extended Release 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
- 504
- 试验地点
- 1
- 主要终点
- sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population
研究概览
简要总结
The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were safe.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell count (WBC >10,000/mm3) or greater than 15% immature neutrophils were included. Patients were to have a chest radiograph demonstrating evidence of a new infiltrate or consolidation, and a Modified Fine Risk score of ≤ 70 (Fine Class I and II).
排除标准
- •Patients who were treated with any systemic antibiotic of greater than 1 dose or 1 combination dose (such as cephalosporin and macrolide) within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; were hospitalized in the previous 14 days or had an infection acquired in the hospital, and who were residents of a long-term care facility were excluded.
研究组 & 干预措施
1
Experimental
干预措施: clarithromycin extended release (ER) (Drug)
2
Experimental
干预措施: azithromycin SR (Drug)
结局指标
主要结局
sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population
时间窗: Test of Cure (TOC) visit (Day 14-21)
次要结局
- physical examination(Baseline)
- bacteriologic response (eradication rate) in the Bacteriological Per Protocol population(TOC visit)
- investigator assessment of clinical response in the Clinical Per Protocol population(TOC visit)
- sponsor assessment of clinical response by baseline pathogen(End of Treatment (EOT) visit (Day 8-11) and TOC visit)
- sponsor assessment of clinical response in the non-primary population(EOT visit and TOC visit)
- sponsor assessment of clinical responses in the Clinical Per Protocol population(EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35))
- susceptibilities of baseline pathogens(Study endpoint)
- adverse events(Continuous)
- vital signs(Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit)
- clinical laboratory assessments (blood chemistry and hematology)(Baseline 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 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 Sinus Infections in AdultsMaxillary SinusitisNCT00643409Pfizer541
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
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
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