A Comparison of Cefditoren Pivoxil 10 mg/kg/Day and Cefditoren Pivoxil 20 mg/kg/Day in Treatment of Childhood With Acute Rhinosinusitis
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- sinus symptoms scores
研究概览
简要总结
Cefditoren pivoxil has been used in rhinosinusitis treatment. However, little is known about the efficacy of this drug at low and high doses.
详细描述
The investigation was a randomized, investigator-blinded, and parallel study, conducted in patients (age 1-15 years) with acute rhinosinusitis. Two groups of patients were randomized received low (10 MKD) or high (20 MKD) of drug for 14 days. Changes in sinus symptoms scores, response rate and adverse effect were evaluated at days 7 and 14. Relapse rate was recorded at days 21 and 28. Recurrence of sinus symptoms at day 60 were assessed.
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
- Single (Investigator)
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children age 1-15 years old diagnosed acute rhinosinusitis
排除标准
- •poor compliance
- •other infections
研究组 & 干预措施
cefditoren pivoxil
cefditoren 10 mg/kg/day for 14 days
干预措施: cefditoren pivoxil (Drug)
cefditoren pivoxil high dose
cefditoren 20 MKD were used to compare efficacy of treatment.
干预措施: cefditoren pivoxil (Drug)
结局指标
主要结局
sinus symptoms scores
时间窗: 14 days
Change of sinus sympotms scores from baseline in 2 weeks
次要结局
- relapse rate(at day 28)
研究者
Orapan Poachanukoon
Associate Professor
Thammasat University