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

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Tract Infection
• Intervention / Treatment: Drug: Methylprednisolone

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1week old ~ 16 years old children with UTI

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UTI treated with Methylprednisolone; UTI treated with Methylprednisolone in addition to the effective antibiotics	Drug: Methylprednisolone; Add methylprednisolone in addition to the experience antibiotics in children with urinary tract infection to see if the frequency of the renal scar formation could be decreased; Other Names: Adrenal corticosteroid
No Intervention: UTI not treated with Methylprednisolone; UTI treated with effective antibiotics only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with renal scar formation	Check the renal scar formation 6.5 months after the UTI	6.5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the hospitalization	Check the duration of the hospitalization	the duration patient in the hospital, may be about 5 days
Expense of the hospitalization	Check the expense of the hospitalization	the duration patient in the hospital, may be about 5 days

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: December 31, 2014
• First Submitted That Met QC Criteria: January 4, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Estimate): January 6, 2015
• Last Update Submitted That Met QC Criteria: January 4, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: methylprednisolone; urinary tract infection
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: B-BR-103-050