Study of the Effect of Acetylcysteine on Inflammation Biomarkers in Pediatric Acute Pyelonephritis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Serum procalcitonin
研究概览
简要总结
In different studies, it has been shown that "antioxidant" utilization has favorable therapeutic effects not only on control of acute symptoms but also on prevention of delayed problems from acute and chronic pyelonephritis.
According to the efficacy of acetylcysteine as a potent antioxidant, safety of this drug and side effects of similar or either less than placebo, this study was designed to evaluate the efficacy of this drug on inflammatory biomarkers of pediatric acute pyelonephritis. It is a triple-blind placebo controlled study on a population of 64 patients 1-16 years old that have "definite" or "probable" diagnosis of acute pyelonephritis in "Mofid" hospital.
After randomization, patients will be given acetylcysteine or placebo with dosing according to their weight. Results of treatment are evaluated according to serum procalcitonin, C reactive protein and leukocyte count before drug prescription (baseline) and 5 days after drug prescription. Side effects are also recorded in both groups. Patients will be receiving their routine antimicrobial drugs in addition to acetylcysteine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 1 and 16
- •Having the diagnosis of "definite" or "probable" urinary tract infection according to guidelines of "pediatric infectious disease research center
排除标准
- •Patients younger than 1 or older than 16 years old
- •Patients without the diagnosis of "definite" or "probable" urinary tract infection according to guidelines of "pediatric infectious disease research center"
- •Patients with acute/ chronic infectious or inflammatory diseases other than pyelonephritis.
研究组 & 干预措施
Acetylcysteine
Effervescent tablet of acetylcysteine 600 mg dosing according to weight, until 5 days. Dose for patients more than 30 kg: 1.5 tablet daily 8.5-30 kg: 1 tablet daily less than 8.5 kg: 70 mg/kg
干预措施: Acetylcysteine (Drug)
Placebo
Placebo effervescent tablet of acetylcysteine 600 mg dosing according to weight, until 5 days. Dose for patients more than 30 kg: 1.5 tablet daily 8.5-30 kg: 1 tablet daily: more than 30 kg: 1.5 tablet daily 8.5-30 kg: 1 tablet daily less than 8.5 kg: 70 mg/kg
干预措施: placebo acetylcysteine (Drug)
结局指标
主要结局
Serum procalcitonin
时间窗: Change from baseline serum procalcitonin at 5 days
次要结局
- Probable adverse effects (nausea, vomiting, bad tasting, stomatitis, ...)(Participants will be followed for the duration of hospital stay, an expected average of 5 days)
- Serum C Reactive Protein(Change from baseline serum C Reactive Protein at 5 days)
- Leukocyte count(Change from baseline leukocyte count at 5 days)
研究者
Jamshid Salamzadeh, PhD
Clinical Pharmacist
Shahid Beheshti University of Medical Sciences