Multicenter, Open, Randomized Comparative Trial To Compare Bacteriological And Clinical Efficacy Of Azithromycin Versus Amoxicillin In Children With Streptococcus Tonsillitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Bacteriologic success (Eradication: elimination of the original GABS; or Colonization: elimination of the original GABS but isolation of another stain of GABS) or failure (Persistence: presence of original GABS on repeated culture samples) rate
研究概览
简要总结
The primary objective was to compare the bacteriological efficacy at Day 10 of azithromycin pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin pediatric suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15 years with Group A streptococcal acute pharyngitis/tonsillitis. Secondary objectives were assessments of bacteriological efficacy at Day 30 and clinical efficacy at Day 10 and Day 30.
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
- None
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with an acute pharyngitis erythematous or erythematopultaceous with modification of pharynx aspect and fever of ≥38° C, and patients either with or without spontaneous pharyngeal pain or upon swallowing and enlargement of the cervical lymph node (mandibular area) were eligible for inclusion. All subjects should have had a positive rapid strep test and a positive culture for Group A beta-hemolytic streptococcus.
排除标准
- •Patients with pseudomembranous, vesicular, ulcerous or ulceronecrotic pharyngitis were excluded.
研究组 & 干预措施
1
干预措施: Clamoxyl (Drug)
2
干预措施: Zithromax (Drug)
结局指标
主要结局
Bacteriologic success (Eradication: elimination of the original GABS; or Colonization: elimination of the original GABS but isolation of another stain of GABS) or failure (Persistence: presence of original GABS on repeated culture samples) rate
时间窗: Day 10
次要结局
- Bacteriological success or failure rate(Day 30)
- Clinical success (resolution of signs and symptoms, or sufficient improvement; no additional antibacterial therapy indicated) or failure (insufficient improvement or worsening of signs and symptoms; additional antibacterial therapy indicated) rate(Day 10)
- Clinical success or failure rate(Day 30)
- Serious and non-serious adverse events (AEs) rates(continuous)
- Rate of poststreptococcal complications and new disease occurrence since Day 10(Day 30)