Trial record 1 of 1 for:    RIVUR
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Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00405704
First received: November 29, 2006
Last updated: March 19, 2014
Last verified: March 2014

November 29, 2006
March 19, 2014
May 2007
June 2013   (final data collection date for primary outcome measure)
Recurrent febrile or symptomatic urinary tract infection during 2-year follow-up [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Recurrent febrile or symptomatic urinary tract infection during 2-year follow-up
Complete list of historical versions of study NCT00405704 on ClinicalTrials.gov Archive Site
  • Renal scarring based on DMSA scan performed 1 and 2 years after enrollment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Severe renal scarring on outcome scan [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Treatment failure composite based on multiple recurrent UTIs or, in children with baseline scarring of grade 3 or higher, new renal scarring at 12-months or further scarring at any time following recurrent febrile UTI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Presence of E.coli resistant to TMP/SMZ (based on rectal swab) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Recurrent febrile or symptomatic UTI caused by TMP/SMZ-resistant organism [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Renal scarring based on DMSA scan performed 1 and 2 years after enrollment
  • Severe renal scarring on outcome scan
  • Treatment failure composite based on multiple recurrent UTIs or, in children with baseline scarring of grade 3 or higher, new renal scarring at 12-months or further scarring at any time following recurrent febrile UTI
  • Presence of E.coli resistant to TMP/SMZ (based on rectal swab)
  • Recurrent febrile or symptomatic UTI caused by TMP/SMZ-resistant organism
Not Provided
Not Provided
 
Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)

The purpose of this study is to learn whether children with vesicoureteral reflux (VUR) grades I - IV 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.

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. 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%. The primary analysis is intention-to-treat with missing outcome data analyzed as UTI.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Vesico-Ureteral Reflux
  • Urinary Tract Infections
  • 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.
    Other Names:
    • Sulfatrim
    • Bactrim
  • Drug: Placebo
    Cherry flavored liquid suspension matched to active comparator.
  • Active Comparator: Trimethoprim-Sulfamethoxazole
    Intervention: Drug: Trimethoprim-Sulfamethoxazole
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
607
April 2014
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age at randomization: at least 2 months, but less than 6 years of age. Note that children as young as 1 month may be screened for the study.
  • Diagnosed first or second febrile or symptomatic UTI within 112 days prior to randomization
  • Presence of Grade I- IV VUR based on radiographic VCUG performed within 112 days of diagnosis of index UTI.
  • Appropriately treated index febrile or symptomatic UTI

Exclusion Criteria:

  • Index UTI diagnosis more than 112 days prior to randomization
  • History of more than two UTIs prior to randomization
  • For patients less than 6 months of age at randomization, gestational age less than 34 weeks
  • Co-morbid urologic anomalies
  • Hydronephrosis, SFU Grade 4
  • Ureterocele
  • Urethral valve
  • Solitary kidney
  • Profoundly decreased renal size unilaterally on ultrasound,(based on 2 standard deviations below the mean for age and length) performed within 112 days after diagnosis of index UTI
  • Multicystic dysplastic kidney
  • Neurogenic bladder
  • Pelvic kidney or fused kidney
  • Known sulfa allergy, inadequate renal or hepatic function, G6PD deficiency or other conditions that are contraindications for use of TMP/SMZ
  • History of other renal injury/disease
  • Unable to complete the study protocol
  • Congenital or acquired immunodeficiency
  • Underlying anomalies or chronic diseases that could potentially interfere with response to therapy such as chronic gastrointestinal conditions (i.e., malabsorption, inflammatory bowel disease), liver or kidney failure, or malignancy.
  • Complex cardiac disease as defined in the Manual of Procedures.
  • Any known syndromes associated with VUR or bladder dysfunction
  • Index UTI not successfully treated
  • Unlikely to complete follow-up
  • Family history of anaphylactic reaction to sulfa medications
Both
2 Months to 71 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00405704
DK074059 (IND), U01 DK074059
Yes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Sahar Fathallah, MD University of Alabama, Birmingham, AL
Principal Investigator: Myra A Carpenter, PhD University of NC at Chapel Hill, Chapel Hill, NC
Principal Investigator: Caleb P. Nelson, MD, MPH Children's Hospital of Boston, Boston, MA
Principal Investigator: Eileen Brewer, 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 Research Institute
Principal Investigator: Mary Ann Queen, 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 & Science University, Portland, OR
Principal Investigator: Amy Renwick, MD Alfred I. duPont Hospital for Children, Wilmington, DE
Principal Investigator: Earl Y. Cheng, MD Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL
Principal Investigator: Milan Nadkarni, MD 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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP