NCT00643149已完成3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial Of Azithromycin SR Versus Amoxicillin For The Treatment Of Group A Β-Hemolytic Streptococcal Pharyngitis/Tonsillitis In Children
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
- 693
- 试验地点
- 1
- 主要终点
- Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population
研究概览
简要总结
The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat.
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
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae ("strawberry tongue"). Subjects were required to have a positive rapid antigen detection test (RADT) or a positive culture of the pharynx or tonsils for GABHS.
排除标准
- •Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days.
研究组 & 干预措施
1
Experimental
干预措施: amoxicillin (Drug)
2
Experimental
干预措施: azithromycin SR (Drug)
结局指标
主要结局
Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population
时间窗: TOC visit (Day 24-28)
次要结局
- Bacteriologic eradication rate at the Long-Term Follow-Up (LTFU) visit(LTFU Visit (Day 38-45))
- Clinical response (clinical cure or failure) at the TOC visit in the Bacteriologic Per Protocol population(TOC Visit (Day 24-28))
- Clinical response (cure or relapse) at the LTFU visit(LTFU Visit (Day 38-45))
- Pathogen susceptibility versus bacteriologic response(Not reported)
- Adverse events (AEs) were assessed for all treated subjects(Continuous)
- Vital signs and physical examinations were recorded(Baseline and as necessary)
- Clinical laboratory testing (hematology and blood chemistry)(As necessary)
- Azithromycin serum concentrations were determined for patients who vomited within 30 minutes of receiving their azithromycin SR/placebo dose(Day 1)
研究者
研究点 (1)
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