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

NCT ID: NCT02331862

Last Updated: 2015-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

Brief Summary

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.

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.

Conditions

Urinary Tract Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UTI treated with Methylprednisolone

UTI treated with Methylprednisolone in addition to the effective antibiotics

Group Type: EXPERIMENTAL

Methylprednisolone

Intervention Type: DRUG

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

UTI not treated with Methylprednisolone

UTI treated with effective antibiotics only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Adrenal corticosteroid

Eligibility Criteria

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

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

B-BR-103-050

Identifier Type: -

Identifier Source: org_study_id