Vesicoureteral RefluxPhase 3RIVURNCT00405704
Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
A Phase 3 study testing Trimethoprim-Sulfamethoxazole in people with Vesicoureteral Reflux and Urinary Tract Infections, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 19 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 71 months
- Conditions the study is for
- Vesicoureteral Reflux, Urinary Tract Infections
- What is being tested?
- Trimethoprim-Sulfamethoxazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 607 participants
- Where
- 19 sitesUnited States
- Study dates
- May 2007to May 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Akron Children's Hospital
Akron, Ohio, 44308
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
University of Alabama
Birmingham, Alabama, 35233
Children's Hospital of Boston
Boston, Massachusetts, 02115
Women and Children's Hospital of Buffalo
Buffalo, New York, 14222
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Children's Hospital of Michigan
Detroit, Michigan, 48201
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Texas Children's Hospital
Houston, Texas, 77030
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of Wisconsin Children's Hospital
Madison, Wisconsin, 53792
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University
Portland, Oregon, 97239
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Vesicoureteral Reflux, Urinary Tract Infections
- Being tested
- Trimethoprim-Sulfamethoxazole, Placebo
- Keywords
- Vesicoureteral Reflux, Urinary Tract Infections, Renal Scarring, Antibiotic Resistance, Controlled Clinical Trial, Trimethoprim-Sulfamethoxazole, Children
- Medical subject headings
- Vesico-Ureteral Reflux, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimethoprim-SulfamethoxazoleDrug
Also called Sulfatrim, Bactrim
Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
PlaceboDrug
Cherry flavored liquid suspension matched to active comparator.
| Study group | Role | What they receive |
|---|---|---|
| Trimethoprim-Sulfamethoxazole | Active comparator | Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily. Receives: Drug: Trimethoprim-Sulfamethoxazole |
| Placebo | Placebo comparator | Cherry-flavored liquid suspension matched to active comparator. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up
Measured: 2 years
Secondary outcomes (7)
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)
Measured: 2 years
Recurrent Febrile or Symptomatic UTI With Resistant E. Coli
Measured: 2 years
Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startMay 2007
- Primary completionJun 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Vesicoureteral RefluxStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Sahar Fathallah, MD, Principal investigator, University of Alabama, Birmingham, ALMyra A Carpenter, PhD, Principal investigator, University of NC at Chapel Hill, Chapel Hill, NCCaleb P. Nelson, MD, MPH, Principal investigator, Children's Hospital of Boston, Boston, MAEileen Brewer, MD, Principal investigator, Texas Children's Hospital, Houston, TXSaul P Greenfield, MD, Principal investigator, Women and Children's Hospital of Buffalo, Buffalo, NYAlejandro Hoberman, MD, Principal investigator, Children's Hospital of Pittsburgh, Pittsburgh, PARon Keren, MD, MPH, Principal investigator, Children's Hospital of Philadelphia, Philadelphia, PABradley P Kropp, MD, Principal investigator, University of Oklahoma, Oklahoma City, OK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405704
- Sponsor's protocol ID
- DK074059 (IND)
- Other IDs
- U01DK074059
- Acronym
- RIVUR
- Status last verified
- Apr 2020
- First submitted
- 29 Nov 2006
- Last updated
- 21 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/rivur/?query=rivur
Publications
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.
PubMed 19450818Mathews 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.
PubMed 19570724Keren 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.
PubMed 19018048Greenfield 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.
PubMed 18076937Chesney 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.
PubMed 19018047Keren R. Pediatrics. RIVUR trial. Introduction. Pediatrics. 2008 Dec;122 Suppl 5:S231-2. doi: 10.1542/peds.2008-1285b. No abstract available.
PubMed 19086141Greenfield 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.
PubMed 22910235Hoberman 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.
PubMed 23546617Bhatnagar 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.
PubMed 24151147Chesney 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.
PubMed 23044377Carpenter 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.
PubMed 23753091RIVUR 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.
PubMed 24795142Primack 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.
PubMed 28967387Keren 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.
PubMed 26055855
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
- ClinicalTrials.gov ID
- NCT00405704
- Acronym / sponsor ID
- RIVUR / DK074059 (IND)
- Conditions
- Vesicoureteral Reflux, Urinary Tract Infections
- Keywords
- Vesicoureteral Reflux, Urinary Tract Infections, Renal Scarring, Antibiotic Resistance, Controlled Clinical Trial, Trimethoprim-Sulfamethoxazole, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- May 2007 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Nov 2006 (estimated)
- Results
- Posted 16 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trimethoprim-Sulfamethoxazole | Active comparator | Drug: Trimethoprim-SulfamethoxazoleCherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily. |
| Placebo | Placebo comparator | Drug: PlaceboCherry-flavored liquid suspension matched to active comparator. |
Who may qualify
- Ages
- 2 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimethoprim-SulfamethoxazoleAlso: Sulfatrim, BactrimCherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily. | Drug | Trimethoprim-Sulfamethoxazole |
| PlaceboCherry flavored liquid suspension matched to active comparator. | Drug | Placebo |
Primary outcome
Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up
Time frame: 2 years
7 secondary outcomes
Outcome Renal Scarring
Time frame: 2 years
Severe Renal Scarring on Outcome Scan
Time frame: 2 years
New Renal Scarring on Outcome Scan
Time frame: 2 years
Treatment Failure Composite
Time frame: 2 years
Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)
Time frame: 2 years
Recurrent Febrile or Symptomatic UTI With Resistant E. Coli
Time frame: 2 years
Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19450818Ziessman 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.
- Background: PubMed 19570724Mathews 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.
- Background: PubMed 19018048Keren 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.
- Background: PubMed 18076937Greenfield 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.
- Background: PubMed 19018047Chesney 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.
- Background: PubMed 19086141Keren R. Pediatrics. RIVUR trial. Introduction. Pediatrics. 2008 Dec;122 Suppl 5:S231-2. doi: 10.1542/peds.2008-1285b. No abstract available.
- Background: PubMed 22910235Greenfield 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.
- Background: PubMed 23546617Hoberman 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.
- Background: PubMed 24151147Bhatnagar 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.
- Background: PubMed 23044377Chesney 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 publication: PubMed 23753091Carpenter 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 publication: PubMed 24795142RIVUR 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.
- RIVUR trial web siteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/rivur/?query=rivur
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahar Fathallah, MD principal investigator
University of Alabama, Birmingham, AL
Myra A Carpenter, PhD principal investigator
University of NC at Chapel Hill, Chapel Hill, NC
Caleb P. Nelson, MD, MPH principal investigator
Children's Hospital of Boston, Boston, MA
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trimethoprim-Sulfamethoxazole in people with Vesicoureteral Reflux and Urinary Tract Infections, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00405704, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.