NCT00644293已完成3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A β-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and 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
- 598
- 试验地点
- 1
- 主要终点
- bacteriologic response in the Bacteriologic per Protocol population
研究概览
简要总结
To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for 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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS) pharyngitis/tonsillitis and a positive rapid antigen detection test or positive culture of the pharynx or tonsils for GABHS
排除标准
- •Patients were excluded if they had treatment with any systemic antibiotic within the previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known carriers of GABHS.
研究组 & 干预措施
1
Experimental
干预措施: azithromycin (Zithromax) (Drug)
1
Experimental
干预措施: placebo (Drug)
2
Experimental
干预措施: azithromycin SR (Drug)
2
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
bacteriologic response in the Bacteriologic per Protocol population
时间窗: Test of Cure (TOC) visit (Days 24-28)
次要结局
- summary of baseline susceptibilities(Study endpoint)
- sponsor assessment of clinical response in the Bacteriologic per Protocol population(TOC visit)
- bacteriologic response for the remaining study populations(TOC visit)
- sponsor assessment of clinical response for the Bacteriologic per Protocol population(Long-Term Follow-Up (LTFU) visit (Days 38-45))
- bacteriologic response for the Bacteriologic per Protocol population(TOC visit)
- adverse events(Continuous)
研究者
研究点 (1)
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