To Study the Effect of Adjunctive Oral Methylprednisolone Therapy in Pediatric Urinary Tract Infection
Primary Purpose
Urinary Tract Infection
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infection focused on measuring urinary tract infection, methylprednisolone
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
UTI treated with Methylprednisolone
UTI not treated with Methylprednisolone
Arm Description
UTI treated with Methylprednisolone in addition to the effective antibiotics
UTI treated with effective antibiotics only
Outcomes
Primary Outcome Measures
The proportion of patients with renal scar formation
Check the renal scar formation 6.5 months after the UTI
Secondary Outcome Measures
Duration of the hospitalization
Check the duration of the hospitalization
Expense of the hospitalization
Check the expense of the hospitalization
Full Information
NCT ID
NCT02331862
First Posted
December 31, 2014
Last Updated
January 4, 2015
Sponsor
National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02331862
Brief Title
To Study the Effect of Adjunctive Oral Methylprednisolone Therapy in Pediatric Urinary Tract Infection
Official Title
To Study the Effect of Adjunctive Oral Methylprednisolone Therapy in Pediatric Urinary Tract Infection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Purposes of this study will be as follows:
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.
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
urinary tract infection, methylprednisolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UTI treated with Methylprednisolone
Arm Type
Experimental
Arm Description
UTI treated with Methylprednisolone in addition to the effective antibiotics
Arm Title
UTI not treated with Methylprednisolone
Arm Type
No Intervention
Arm Description
UTI treated with effective antibiotics only
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Adrenal corticosteroid
Intervention Description
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
Primary Outcome Measure Information:
Title
The proportion of patients with renal scar formation
Description
Check the renal scar formation 6.5 months after the UTI
Time Frame
6.5 months
Secondary Outcome Measure Information:
Title
Duration of the hospitalization
Description
Check the duration of the hospitalization
Time Frame
the duration patient in the hospital, may be about 5 days
Title
Expense of the hospitalization
Description
Check the expense of the hospitalization
Time Frame
the duration patient in the hospital, may be about 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
To Study the Effect of Adjunctive Oral Methylprednisolone Therapy in Pediatric Urinary Tract Infection
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