Efficacy And Safety Of Azithromycin To Achieve Remissionin In Children With Steroid Sensitive Nephrotic Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Early remission.
研究概览
简要总结
To compare efficacy and safety of Azithromycin versus control in children with steroid sensitive nephrotic syndrome
详细描述
It is a randomized controlled trial. Total 160 children meeting inclusion criteria will be included in the study. Selected children will be divided into 2 groups. one group will be given Azithromycin at 10mg/kg/day (1 dose per day) for 3 days along with standard course of steroids. 2nd group will be given standard course of treatment. All patients will be followed up for 1 month and remission will be noted. All data will be collected through specially designed performa. Patient's safety and Efficacy of drug in Achieving early Remission will be closely monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children age 2 to 14 years
- •Both genders
- •Children having primary nephrotic syndrome
排除标准
- •Children with steroid resistant nephrotic syndrome
- •Children with secondary causes of nephrotic syndrome
- •Recent use of azithromycin during last 4 weeks
- •Severe systemic infection requiring antibiotics
- •Chronic liver disease Prolong QT Interval or history of cardiac arythmias
研究组 & 干预措施
Group taking Azithromycin and Steroids
80 Children will be assigned group A in which children will be given Azithromycin at 10mg /kg/day Per oral along with standard course of treatment.
干预措施: Azithromycin and steroids (Drug)
Group Taking steroids
80 Children will be assigned group B in which children will be only given standard course of steroids.
干预措施: steroids (Drug)
结局指标
主要结局
Early remission.
时间窗: 14 days
This study will make an impact on understanding the effectiveness and safety of azithromycin in children regain early remission. It will be classified as either complete or partial remission. Complete remission will be indicated as negative or having trace proteinuria and will be measured with the help of early morning urine dipstick test for proteinuria for 3 consecutive days, serum albumin level of more than 2.5g/dl and resolution of edema. Partial remission will be defined as serum albumin level of more than 2.5g/dl but with persistent proteinuria. Early Remission and relapse will be presented as frequency and percentage. Both groups will be compared for early remission by chi square test.
次要结局
- Relapse reduction(14 days)
研究者
Ummara Subhani
Principal investigator
University of Child Health Sciences and Children's Hospital, Lahore