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NCT00405704 · ClinicalTrials.gov registry record · Phase 3
Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
A Phase 3 study of Urinary Tract Infections and Vesicoureteral Reflux, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 607
- Enrollment target
- 19
- Study locations
NCT00405704 is a Phase 3 study of Urinary Tract Infections and Vesicoureteral Reflux that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 607 participants, above the 440-participant average among 34 other Urinary Tract Infections trials with a reported enrollment target (38% higher). The trial reports 19 study locations across 16 states.
The verdict
NCT00405704, a Phase 3 study of Urinary Tract Infections and Vesicoureteral Reflux, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 607 participants
- Enrollment target
- 19
- Study locations
Study Summary
In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Trimethoprim-Sulfamethoxazole
Study Locations (19)
Pennsylvania
- Penn State Hershey Medical Center - Hershey
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh - Pittsburgh
Ohio
- Akron Children's Hospital - Akron
- Cincinnati Children's Hospital - Cincinnati
Alabama
- University of Alabama - Birmingham
Delaware
- Alfred I. duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Illinois
- Ann & Robert Lurie Children's Hospital of Chicago - Chicago
Maryland
- Johns Hopkins School of Medicine - Baltimore
Massachusetts
- Children's Hospital of Boston - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 607 participants |
| Start Date | 2007-05 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00405704
The ClinicalTrials.gov registry entry for NCT00405704 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 607 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 440-participant average among 34 other Urinary Tract Infections trials with a reported enrollment target (38% higher). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Urinary Tract Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00405704 reports 19 study locations spanning 16 distinct geographic areas - top geographies include Pennsylvania, Ohio, Alabama.
Frequently Asked Questions
What is clinical trial NCT00405704 about?
NCT00405704 is a clinical study titled "Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)". In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) prophylaxis in preventing r...
What is the current status of trial NCT00405704?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 607 participants. The study started on 2007-05. Estimated completion is 2014-05.
What conditions does trial NCT00405704 study?
This clinical trial studies the following conditions: Urinary Tract Infections, Vesicoureteral Reflux.
What interventions are being tested in trial NCT00405704?
The interventions under investigation include: Placebo (DRUG), Trimethoprim-Sulfamethoxazole (DRUG).
Who is sponsoring clinical trial NCT00405704?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00405704 being conducted?
This trial has 19 study locations across Alabama, Delaware, District of Columbia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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