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临床试验/NCT02331862
NCT02331862Unknown3 期

To Study the Effect of Adjunctive Oral Methylprednisolone Therapy in Pediatric Urinary Tract Infection

National Cheng-Kung University Hospital0 个研究点目标入组 160 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
160
主要终点
The proportion of patients with renal scar formation

研究概览

简要总结

Purposes of this study will be as follows:

  1. To design a prospective, randomized, and open-labeled study to investigate the effect and the side effect of MPD in combination with conventional antibiotics to affect clinical course, outcome, and medical expenses.
  2. To compare level of the urinary and serum cytokines before and after received MPD for the following sub-aim:

I. To determine the population who is benefit from MPD to reduce the severity of clinical course and subsequent renal scarring.

II. To understand the mechanism by which the MPD could shorten the clinical course and reduce the renal scarring.

详细描述

The urinary tract infection (UTI) is a common etiology of the febrile children and the acute pyelonephritis (APN) happen in 70% children with the first febrile UTI. After the first APN, the irreversible renal scarring takes place in about 40% patients. The sequela of the renal scarring includes chronic kidney disease, hypertension, the complication during the pregnancy, and even the end stage of renal diseases. Due to the progression of the pathophysiology of the pyelonephritis and the renal scarring in the past years, we understand that the inflammation is one of the important mechanisms. Therefore, there are many animal studies clarifying the role of the anti-inflammation or antioxidant to reduce the renal scarring. In our previous studies, Dr. Chiou Y.Y. and colleagues has provided the evidence that the adjunctive methylprednisolone (MPD) can decrease the risk of the renal scarring for patients with high risk APN, which was defined as inflammatory volume more than 4.6 mL on technetium-99m-labeled dimercaptosuccinic acid scan or abnormal renal ultrasonography results. Our study is the first human study demonstrating the solution for the renal scarring. However, whether this result can be applied to the whole spectrum of the UTI is still unknown. Purposes of this study will be as follows:

  1. To design a prospective, randomized, and open-labeled study to investigate the effect and the side effect of MPD in combination with conventional antibiotics to affect clinical course, outcome, and medical expenses.
  2. To compare level of the urinary and serum cytokines before and after received MPD for the following sub-aim:

I. To determine the population who is benefit from MPD to reduce the severity of clinical course and subsequent renal scarring.

II. To understand the mechanism by which the MPD could shorten the clinical course and reduce the renal scarring.

According to these studies, we will provide a new and effective guideline to shorten disease course, save medical expenses, and decrease the risk for renal scarring sequela.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Week 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 1week old ~ 16 years old children with UTI

排除标准

  • Previous UTI
  • Known GU tract obstruction
  • Severe sepsis with vital signs change
  • Antibiotics used

研究组 & 干预措施

UTI treated with Methylprednisolone

Experimental

UTI treated with Methylprednisolone in addition to the effective antibiotics

干预措施: Methylprednisolone (Drug)

结局指标

主要结局

The proportion of patients with renal scar formation

时间窗: 6.5 months

Check the renal scar formation 6.5 months after the UTI

次要结局

  • Expense of the hospitalization(the duration patient in the hospital, may be about 5 days)
  • Duration of the hospitalization(the duration patient in the hospital, may be about 5 days)

研究者

申办方类型
Other
责任方
Sponsor

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