Efficacy of Levofloxacin Versus Ciprofloxacin in the Treatment of Childhood Typhoid Fever
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Total time required to resolve fever
研究概览
简要总结
Sample size of 360 children with typhoid fever were enrolled and randomly divided in two groups. All the children were enrolled in the trial from Pediatrics emergency. Informed consent was obtained from parents. Demographics (name, age of child, sex of the child, duration of fever, weight, season, socioeconomic status and residence) were noted. Then children were admitted and randomly divided in two groups by using lottery method. In group A, children were given oral 200 mg levofloxacin tablet. In group B, children were given oral 900-1,000 mg ciprofloxacin tablet. All children were followed-up pediatric wards for 7 days. If fever was resolved within 5 days (body temperature falls <99oF and remain stable for at least 5 days), then efficacy was labeled. Total time required to resolve fever i.e. body temperature <99oF in all children was also noted. All this information was recorded
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 (Participant)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of age 1-12 years
- •Typhoid fever
- •Confirmed on blood culture
排除标准
- •Recurrent typhoid within 3 months
- •Intestinal perforation
- •Evidence of progressive or complicated disease
- •Inability to swallow oral medication
- •Hypersensitivity to trial drugs
- •Already taken fluoroquinolone, third generation cephalosporin or macrolide in last week
研究组 & 干预措施
Group A with oral 200 mg levofloxacin tablet
Group A included 180 participants. They were given oral 200 mg levofloxacin tablet. All children were followed-up pediatric wards for 7 days. If fever was resolved within 5 days (body temperature falls <99oF and remain stable for at least 5 days), then efficacy was labeled. Total time required to resolve fever i.e. body temperature <99oF in all children was also noted.
干预措施: Levofloxacin (Drug)
Group B with oral 900-1,000 mg ciprofloxacin tablet
. In group B, children were given oral 900-1,000 mg ciprofloxacin tablet. All children were followed-up pediatric wards for 7 days. If fever was resolved within 5 days (body temperature falls <99oF and remain stable for at least 5 days), then efficacy was labeled. Total time required to resolve fever i.e. body temperature <99oF in all children was also noted
干预措施: ciprofloxacin (Drug)
结局指标
主要结局
Total time required to resolve fever
时间窗: 5 days
Clinical efficacy involved resolution of fever within 5 days (body temperature falls \<99oF and remain stable for at least 5 days). Total time required to resolve fever i.e. body temperature \<99oF in all children was also noted.
次要结局
未报告次要终点
研究者
Muhammad Iqbal
Principal Investigator
Avicenna Medical College Lahore