Back to resultsRandomized Intervention for Children With Vesicoureteral Reflux (RIVUR) (RIVUR)
Primary Purpose
Vesicoureteral Reflux, Urinary Tract Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Trimethoprim-Sulfamethoxazole
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Vesicoureteral Reflux focused on measuring Vesicoureteral Reflux, Urinary Tract Infections, Renal Scarring, Antibiotic Resistance, Controlled Clinical Trial, Trimethoprim-Sulfamethoxazole, Children
Eligibility Criteria
Inclusion Criteria:
- Age at randomization: at least 2 months, but less than 6 years of age. Note that children as young as 1 month were 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 voiding cystourethrogram (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, Glucose-6-phosphate dehydrogenase 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
Sites / Locations
- University of Alabama
- Alfred I. duPont Hospital for Children
- Children's National Medical Center
- Ann & Robert Lurie Children's Hospital of Chicago
- Johns Hopkins School of Medicine
- Children's Hospital of Boston
- Children's Hospital of Michigan
- Children's Mercy Hospital
- Women and Children's Hospital of Buffalo
- Wake Forest University Baptist Medical Center
- Akron Children's Hospital
- Cincinnati Children's Hospital
- University of Oklahoma
- Oregon Health & Science University
- Penn State Hershey Medical Center
- Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh
- Texas Children's Hospital
- University of Wisconsin Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Trimethoprim-Sulfamethoxazole
Placebo
Arm Description
Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
Cherry-flavored liquid suspension matched to active comparator.
Outcomes
Primary Outcome Measures
Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up
Secondary Outcome Measures
Outcome Renal Scarring
Renal scarring was defined as a decreased uptake of tracer that was associated with loss of contours or the presence of cortical thinning. Outcome dimercaptosuccinic acid (DMSA) scan was performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.
Severe Renal Scarring on Outcome Scan
Severe renal scarring was defined as scarring in more than 4 of 12 segments in at least one kidney or global atrophy characterized by diffusely scarred and shrunken kidney. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.
New Renal Scarring on Outcome Scan
New renal scarring was defined as scarring on the outcome renal scan with technetium -99m-labeled dimercaptosuccinic acid that was not present at baseline. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.
Treatment Failure Composite
Treatment failure was defined as the occurrence of two febrile urinary tract infections (UTIs), one febrile UTI and three symptomatic UTIs, four symptomatic UTIs, or new or worsening renal scarring on an interim scan (e.g,, the 12-month visit); renal scans from the 2-year visit are NOT considered in the treatment failure criteria.
Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)
Recurrent Febrile or Symptomatic UTI With Resistant E. Coli
Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen
Full Information
NCT ID
NCT00405704
First Posted
November 29, 2006
Last Updated
April 13, 2020
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT00405704
Brief Title
Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
Acronym
RIVUR
Official Title
Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2007 (Actual)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
This multicenter, randomized, double-blind, placebo-controlled trial was 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 were randomly assigned to treatment for 2 years with daily antimicrobial prophylaxis (trimethoprim-sulfamethoxazole) or placebo. The study was designed to recruit 600 children (approximately 300 in each treatment group). The protocol encouraged prompt evaluation of children with UTI symptoms and early therapy of culture-proven UTIs. It was 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 were assessed periodically throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vesicoureteral Reflux, Urinary Tract Infections
Keywords
Vesicoureteral Reflux, Urinary Tract Infections, Renal Scarring, Antibiotic Resistance, Controlled Clinical Trial, Trimethoprim-Sulfamethoxazole, Children
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
607 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trimethoprim-Sulfamethoxazole
Arm Type
Active Comparator
Arm Description
Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Cherry-flavored liquid suspension matched to active comparator.
Intervention Type
Drug
Intervention Name(s)
Trimethoprim-Sulfamethoxazole
Other Intervention Name(s)
Sulfatrim, Bactrim
Intervention Description
Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Cherry flavored liquid suspension matched to active comparator.
Primary Outcome Measure Information:
Title
Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Outcome Renal Scarring
Description
Renal scarring was defined as a decreased uptake of tracer that was associated with loss of contours or the presence of cortical thinning. Outcome dimercaptosuccinic acid (DMSA) scan was performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.
Time Frame
2 years
Title
Severe Renal Scarring on Outcome Scan
Description
Severe renal scarring was defined as scarring in more than 4 of 12 segments in at least one kidney or global atrophy characterized by diffusely scarred and shrunken kidney. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.
Time Frame
2 years
Title
New Renal Scarring on Outcome Scan
Description
New renal scarring was defined as scarring on the outcome renal scan with technetium -99m-labeled dimercaptosuccinic acid that was not present at baseline. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.
Time Frame
2 years
Title
Treatment Failure Composite
Description
Treatment failure was defined as the occurrence of two febrile urinary tract infections (UTIs), one febrile UTI and three symptomatic UTIs, four symptomatic UTIs, or new or worsening renal scarring on an interim scan (e.g,, the 12-month visit); renal scans from the 2-year visit are NOT considered in the treatment failure criteria.
Time Frame
2 years
Title
Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)
Time Frame
2 years
Title
Recurrent Febrile or Symptomatic UTI With Resistant E. Coli
Time Frame
2 years
Title
Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age at randomization: at least 2 months, but less than 6 years of age. Note that children as young as 1 month were 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 voiding cystourethrogram (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, Glucose-6-phosphate dehydrogenase 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar Fathallah, MD
Organizational Affiliation
University of Alabama, Birmingham, AL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myra A Carpenter, PhD
Organizational Affiliation
University of NC at Chapel Hill, Chapel Hill, NC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Caleb P. Nelson, MD, MPH
Organizational Affiliation
Children's Hospital of Boston, Boston, MA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eileen Brewer, MD
Organizational Affiliation
Texas Children's Hospital, Houston, TX
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saul P Greenfield, MD
Organizational Affiliation
Women and Children's Hospital of Buffalo, Buffalo, NY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alejandro Hoberman, MD
Organizational Affiliation
Children's Hospital of Pittsburgh, Pittsburgh, PA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ron Keren, MD, MPH
Organizational Affiliation
Children's Hospital of Philadelphia, Philadelphia, PA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bradley P Kropp, MD
Organizational Affiliation
University of Oklahoma, Oklahoma City, OK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ranjiv Mathews, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tej K Mattoo, MD,DCH, FRCP
Organizational Affiliation
Wayne State University School of Medicine, Detroit, MI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
H. Gil Rushton, MD, FAAP
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary Ann Queen, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Russell W Chesney, MD
Organizational Affiliation
Le Bonheur Children's Medical Center, Memphis, TN
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Steven J Skoog, MD FACS,FAAP
Organizational Affiliation
Oregon Health & Science University, Portland, OR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amy Renwick, MD
Organizational Affiliation
Alfred I. duPont Hospital for Children, Wilmington, DE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Earl Y. Cheng, MD
Organizational Affiliation
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Milan Nadkarni, MD
Organizational Affiliation
Wake Forest University Baptist Medical Center, Winston-Salem, NC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Caleb P Nelson, MD, MPH
Organizational Affiliation
Children's Hospital of Boston, Boston, MA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William R DeFoor, Jr, MD, MPH
Organizational Affiliation
Cincinnati Children's Hospital, Cincinnati, OH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan McMahon, MD
Organizational Affiliation
Akron Children's Hospital, Akron, OH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ross Decter, MD
Organizational Affiliation
Penn State Hershey Medical Center, Hershey, PA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharon M Bartosh, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Ann & Robert Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Children's Hospital of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Women and Children's Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin Children's Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/rivur/?query=rivur
IPD Sharing URL
https://repository.niddk.nih.gov/studies/rivur/?query=rivur
Citations:
PubMed Identifier
19450818
Citation
Ziessman HA, Majd M. Importance of methodology on (99m)technetium dimercapto-succinic acid scintigraphic image quality: imaging pilot study for RIVUR (Randomized Intervention for Children With Vesicoureteral Reflux) multicenter investigation. J Urol. 2009 Jul;182(1):272-9. doi: 10.1016/j.juro.2009.02.144. Epub 2009 May 17.
Results Reference
background
PubMed Identifier
19570724
Citation
Mathews R, Carpenter M, Chesney R, Hoberman A, Keren R, Mattoo T, Moxey-Mims M, Nyberg L, Greenfield S. Controversies in the management of vesicoureteral reflux: the rationale for the RIVUR study. J Pediatr Urol. 2009 Oct;5(5):336-41. doi: 10.1016/j.jpurol.2009.05.010. Epub 2009 Jul 1.
Results Reference
background
PubMed Identifier
19018048
Citation
Keren R, Carpenter MA, Hoberman A, Shaikh N, Matoo TK, Chesney RW, Matthews R, Gerson AC, Greenfield SP, Fivush B, McLurie GA, Rushton HG, Canning D, Nelson CP, Greenbaum L, Bukowski T, Primack W, Sutherland R, Hosking J, Stewart D, Elder J, Moxey-Mims M, Nyberg L. Rationale and design issues of the Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) study. Pediatrics. 2008 Dec;122 Suppl 5(Suppl 5):S240-50. doi: 10.1542/peds.2008-1285d.
Results Reference
background
PubMed Identifier
18076937
Citation
Greenfield SP, Chesney RW, Carpenter M, Moxey-Mims M, Nyberg L, Hoberman A, Keren R, Matthews R, Mattoo T. Vesicoureteral reflux: the RIVUR study and the way forward. J Urol. 2008 Feb;179(2):405-7. doi: 10.1016/j.juro.2007.10.100. No abstract available.
Results Reference
background
PubMed Identifier
19018047
Citation
Chesney RW, Carpenter MA, Moxey-Mims M, Nyberg L, Greenfield SP, Hoberman A, Keren R, Matthews R, Matoo TK; members of the RIVUR Steering Committee. Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR): background commentary of RIVUR investigators. Pediatrics. 2008 Dec;122 Suppl 5(0 5):S233-9. doi: 10.1542/peds.2008-1285c.
Results Reference
background
PubMed Identifier
19086141
Citation
Keren R. Pediatrics. RIVUR trial. Introduction. Pediatrics. 2008 Dec;122 Suppl 5:S231-2. doi: 10.1542/peds.2008-1285b. No abstract available.
Results Reference
background
PubMed Identifier
22910235
Citation
Greenfield SP, Carpenter MA, Chesney RW, Zerin JM, Chow J. The RIVUR voiding cystourethrogram pilot study: experience with radiologic reading concordance. J Urol. 2012 Oct;188(4 Suppl):1608-12. doi: 10.1016/j.juro.2012.06.032. Epub 2012 Aug 19.
Results Reference
background
PubMed Identifier
23546617
Citation
Hoberman A, Shaikh N, Bhatnagar S, Haralam MA, Kearney DH, Colborn DK, Kienholz ML, Wang L, Bunker CH, Keren R, Carpenter MA, Greenfield SP, Pohl HG, Mathews R, Moxey-Mims M, Chesney RW. Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters. JAMA Pediatr. 2013 Jun;167(6):561-6. doi: 10.1001/jamapediatrics.2013.1050.
Results Reference
background
PubMed Identifier
24151147
Citation
Bhatnagar S, Hoberman A, Kearney DH, Shaikh N, Moxey-Mims MM, Chesney RW, Carpenter MA, Greenfield SP, Keren R, Mattoo TK, Mathews R, Gravens-Mueller L, Ivanova A. Development and impact of an intervention to boost recruitment in a multicenter pediatric randomized clinical trial. Clin Pediatr (Phila). 2014 Feb;53(2):151-7. doi: 10.1177/0009922813506961. Epub 2013 Oct 22.
Results Reference
background
PubMed Identifier
23044377
Citation
Chesney RW, Patters AB. Childhood vesicoureteral reflux studies: registries and repositories sources and nosology. J Pediatr Urol. 2013 Dec;9(6 Pt A):731-7. doi: 10.1016/j.jpurol.2012.09.003. Epub 2012 Oct 5.
Results Reference
background
PubMed Identifier
23753091
Citation
Carpenter MA, Hoberman A, Mattoo TK, Mathews R, Keren R, Chesney RW, Moxey-Mims M, Greenfield SP; RIVUR Trial Investigators. The RIVUR trial: profile and baseline clinical associations of children with vesicoureteral reflux. Pediatrics. 2013 Jul;132(1):e34-45. doi: 10.1542/peds.2012-2301. Epub 2013 Jun 10.
Results Reference
result
PubMed Identifier
24795142
Citation
RIVUR Trial Investigators; Hoberman A, Greenfield SP, Mattoo TK, Keren R, Mathews R, Pohl HG, Kropp BP, Skoog SJ, Nelson CP, Moxey-Mims M, Chesney RW, Carpenter MA. Antimicrobial prophylaxis for children with vesicoureteral reflux. N Engl J Med. 2014 Jun 19;370(25):2367-76. doi: 10.1056/NEJMoa1401811. Epub 2014 May 4.
Results Reference
result
PubMed Identifier
28967387
Citation
Primack W, Bukowski T, Sutherland R, Gravens-Mueller L, Carpenter M. What Urinary Colony Count Indicates a Urinary Tract Infection in Children? J Pediatr. 2017 Dec;191:259-261.e1. doi: 10.1016/j.jpeds.2017.08.012. Epub 2017 Sep 28.
Results Reference
derived
PubMed Identifier
26055855
Citation
Keren R, Shaikh N, Pohl H, Gravens-Mueller L, Ivanova A, Zaoutis L, Patel M, deBerardinis R, Parker A, Bhatnagar S, Haralam MA, Pope M, Kearney D, Sprague B, Barrera R, Viteri B, Egigueron M, Shah N, Hoberman A. Risk Factors for Recurrent Urinary Tract Infection and Renal Scarring. Pediatrics. 2015 Jul;136(1):e13-21. doi: 10.1542/peds.2015-0409. Epub 2015 Jun 8.
Results Reference
derived
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Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
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