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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
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection focused on measuring urinary tract infection, methylprednisolone

Eligibility Criteria

1 Week - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 31, 2014
    Last Updated
    January 4, 2015
    Sponsor
    National Cheng-Kung University Hospital
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    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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