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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00405704 |
The purpose of this study is to learn whether all children with vesicoureteral reflux (VUR) should be treated with antibiotics. The study will tell us if prophylactic antibiotic treatment prevents urinary tract infections and renal scarring in children with VUR.
Condition | Intervention | Phase |
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Vesico-Ureteral Reflux Urinary Tract Infections |
Drug: Trimethoprim-Sulfamethoxazole Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) |
Estimated Enrollment: | 600 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Trimethoprim-Sulfamethoxazole
Cherry-flavored liquid suspension in which each 5 mL contains 200 mg sulfamethoxazole and 40 mg trimethoprim. Prophylactic dose is based on trimethoprim component: 3 mg per kg body weight taken once daily.
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2: Placebo Comparator |
Drug: Placebo
Cherry flavored liquid suspension matched to active comparator.
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This multicenter, randomized, double-blind, placebo-controlled trial is designed to determine whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrence of urinary tract infection (UTI) in children with vesicoureteral reflux (VUR). Eligibility criteria are described elsewhere. Patients will be randomly assigned to treatment for 2 years with daily antimicrobial prophylaxis (trimethoprim-sulfamethoxazole) or placebo. The study is designed to recruit 600 children (approximately 300 in each treatment group) over a 24 month period. The protocol will encourage prompt evaluation of children with UTI symptoms and early therapy of culture-proven UTIs. It is expected that approximately 10% of children will have to discontinue study medication due to allergic reactions. Assuming a 20% placebo event rate and 10% non-compliance rate, the study has 83% power to detect an absolute 10% event rate in the antimicrobial prophylaxis group. If the placebo event rate is instead 25%, power is 97% to detect an absolute 10% event rate in the treated group, even if non-compliance is as high as 15%.
In addition to collecting follow-up data on urinary tract infections, renal scarring and antimicrobial resistance, quality of life, compliance, safety parameters, utilization of health resources, and change in VUR will be assessed periodically throughout the study.
Ages Eligible for Study: | 2 Months to 71 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Mark Benfield, MD | University of Alabama, Birmingham, AL |
Principal Investigator: | Myra A Carpenter, PhD | University of NC at Chapel Hill, Chapel Hill, NC |
Principal Investigator: | Ghaleb Daouk, MD | Children's Hospital of Boston, Boston, MA |
Principal Investigator: | Stuart Goldstein, MD | Texas Children's Hospital, Houston, TX |
Principal Investigator: | Saul P Greenfield, MD | Women and Children's Hospital of Buffalo, Buffalo, NY |
Principal Investigator: | Alejandro Hoberman, MD | Children's Hospital of Pittsburgh, Pittsburgh, PA |
Principal Investigator: | Ron Keren, MD, MPH | Children's Hospital of Philadelphia, Philadelphia, PA |
Principal Investigator: | Bradley P Kropp, MD | University of Oklahoma, Oklahoma City, OK |
Principal Investigator: | Ranjiv Mathews, MD | Johns Hopkins University |
Principal Investigator: | Tej K Mattoo, MD,DCH, FRCP | Wayne State University School of Medicine, Detroit, MI |
Principal Investigator: | H. Gil Rushton, MD, FAAP | Children's National Medical Center, Washington, DC |
Principal Investigator: | Uri Alon, MD | Children's Mercy Hospital, Kansas City, MO |
Study Chair: | Russell W Chesney, MD | Le Bonheur Children's Medical Center, Memphis, TN |
Principal Investigator: | Steven J Skoog, MD FACS,FAAP | Oregon Health and Science University |
Principal Investigator: | Julie Barthold, MD | Alfred I. duPont Hospital for Children, Wilmington, DE |
Principal Investigator: | Earl Y. Cheng, MD | Children's Memorial Hospital, Chicago, IL |
Principal Investigator: | Gordon McLorie, MD,FAAP,FRCSC | Wake Forest University Baptist Medical Center, Winston-Salem, NC |
Principal Investigator: | Caleb P Nelson, MD, MPH | Children's Hospital of Boston, Boston, MA |
Principal Investigator: | William R DeFoor, Jr, MD, MPH | Cincinnati Children's Hospital, Cincinnati, OH |
Principal Investigator: | Dan McMahon, MD | Akron Children's Hospital, Akron, OH |
Principal Investigator: | Ross Decter, MD | Penn State Hershey Medical Center, Hershey, PA |
Principal Investigator: | Sharon M Bartosh, MD | University of Wisconsin, Madison |
Responsible Party: | NIDDK ( Marva Moxey-Mims, MD, Project Officer ) |
Study ID Numbers: | DK074059, U01 DK074059 |
Study First Received: | November 29, 2006 |
Last Updated: | November 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00405704 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board; Canada: Health Canada |
Vesico-Ureteral Reflux Urinary Tract Infections Renal Scarring Antibiotic Resistance |
Controlled Clinical Trial Trimethoprim-Sulfamethoxazole Children |
Folic Acid Vesico-Ureteral Reflux Trimethoprim Cystocele Sulfamethoxazole |
Urologic Diseases Urinary Bladder Diseases Urinary Tract Infections Trimethoprim-Sulfamethoxazole Combination Cicatrix |
Antimalarials Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Anti-Infective Agents, Urinary Folic Acid Antagonists Renal Agents Infection Pharmacologic Actions |