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NCT01391793 · ClinicalTrials.gov registry record · Phase 3
Corticosteroids for Children With Febrile Urinary Tract Infections
A Phase 3 study of Urinary Tract Infection and Acute Urinary Tract Infection, sponsored by Nader Shaikh.
- Completed
- Registry status
- Phase 3
- Development phase
- 546
- Enrollment target
- 6
- Study locations
NCT01391793: Completed Phase 3 study of Urinary Tract Infection and Acute Urinary Tract Infection, sponsored by Nader Shaikh.
NCT01391793 is a Phase 3 study of Urinary Tract Infection and Acute Urinary Tract Infection that has completed, run by Nader Shaikh. The registered enrollment target is 546 participants, below the 624-participant average among 11 other Urinary Tract Infection trials with a reported enrollment target (12% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01391793, a Phase 3 study of Urinary Tract Infection and Acute Urinary Tract Infection, has completed, sponsored by Nader Shaikh.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 546 participants
- Enrollment target
- 6
- Study locations
Study Summary
In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.
Primary Outcome
Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with scarring by the majority of readers, then the child was determined to have renal scarring.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dexamethasone
Study Locations (6)
District of Columbia
- Children's National Medical Center - Washington D.C.
Ohio
- Nationwide Children's Hospital in Columbus - Columbus
Pennsylvania
- Children's Hospital of Pittsburgh - Pittsburgh
Rhode Island
- Hasbro Children's Hospital - Providence
Utah
- Primary Children's Hospital - Salt Lake City
Wisconsin
- American Family Children's Hospital - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 546 participants |
| Start Date | 2011-09 |
| Est. Completion | 2018-03-30 |
| Phase | Phase 3 |
What the finished NCT01391793 record still lists
NCT01391793 is an interventional study that assigns participants to a tested intervention. The registered 546 participants enrollment target is mid-sized for trials with a published cap, below the 624-participant average among 11 other Urinary Tract Infection trials with a reported enrollment target (12% lower).
The record links to 2 conditions, with Urinary Tract Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01391793 lists 6 locations in 6 states (District of Columbia, Ohio, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT01391793 about?
NCT01391793 is a clinical study titled "Corticosteroids for Children With Febrile Urinary Tract Infections". In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.
What is the current status of trial NCT01391793?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 546 participants. The study started on 2011-09. Estimated completion is 2018-03-30.
What conditions does trial NCT01391793 study?
This clinical trial studies the following conditions: Urinary Tract Infection, Acute Urinary Tract Infection.
What interventions are being tested in trial NCT01391793?
The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT01391793?
This trial is sponsored by Nader Shaikh, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01391793 being conducted?
This trial has 6 study locations across District of Columbia, Ohio, Pennsylvania, Rhode Island, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01391793's enrollment target sits among peer trials
546 3rd of 11 higher than 9 of 11 other Urinary Tract Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Tract Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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