NCT02331862

Brief Summary

Purposes of this study will be as follows:

  1. 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. 2.To compare level of the urinary and serum cytokines before and after received MPD for the following sub-aim:

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

December 31, 2014

Last Update Submit

January 4, 2015

Conditions

Urinary Tract Infection

Keywords

urinary tract infectionmethylprednisolone

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with renal scar formation

    Check the renal scar formation 6.5 months after the UTI

    6.5 months

Secondary Outcomes (2)

  • Duration of the hospitalization

    the duration patient in the hospital, may be about 5 days

  • Expense of the hospitalization

    the duration patient in the hospital, may be about 5 days

Study Arms (2)

UTI treated with Methylprednisolone

EXPERIMENTAL

UTI treated with Methylprednisolone in addition to the effective antibiotics

Drug: Methylprednisolone

UTI not treated with Methylprednisolone

NO INTERVENTION

UTI treated with effective antibiotics only

Interventions

MethylprednisoloneDRUG

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

Also known as: Adrenal corticosteroid
UTI treated with Methylprednisolone

Eligibility Criteria

Age1 Week - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • week old \~ 16 years old children with UTI

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

MethylprednisoloneAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2014

First Posted

January 6, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 6, 2015

Record last verified: 2015-01