Rationale and design issues of the randomized intervention for children with vesicoureteral reflux (RIVUR) study

Ron Keren, Myra A. Carpenter, Alejandro Hoberman, Nader Shaikh, Tej K. Matoo, Russell W. Chesney, Ranjiv Matthews, Arlene C. Gerson, Saul P. Greenfield, Barbara A Fivush, Gordon A. McLurie, H. Gil Rushton, Douglas Canning, Caleb P. Nelson, Lawrence Greenbaum, Timothy Bukowski, William Primack, Richard Sutherland, James Hosking, Dawn Stewart & 3 others Jack Elder, Marva Moxey-Mims, Leroy Nyberg

Research output: Contribution to journalArticle

Abstract

OBJECTIVE. Our goal is to determine if antimicrobial prophylaxis with trimethoprim/sulfamethoxazole prevents recurrent urinary tract infections and renal scarring in children who are found to have vesicoureteral reflux after a first or second urinary tract infection. DESIGN, PARTICIPANTS, AND METHODS. The Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) study is a double-blind, randomized, placebo-controlled trial. Six hundred children aged 2 to 72 months will be recruited from both primary and subspecialty care settings at clinical trial centers throughout North America. Children who are found to have grades I to IV vesicoureteral reflux after the index febrile or symptomatic urinary tract infection will be randomly assigned to receive daily doses of either trimethoprim/sulfamethoxazole or placebo for 2 years. Scheduled follow-up contacts include in-person study visits every 6 months and telephone interviews every 2 months. Biospecimens (urine and blood) and genetic specimens (blood) will be collected for future studies of the genetic and biochemical determinants of vesicoureteral reflux, recurrent urinary tract infection, renal insufficiency, and renal scarring. RESULTS. The primary outcome is recurrence of urinary tract infection. Secondary outcomes include time to recurrent urinary tract infection, renal scarring (assessed by dimercaptosuccinic acid scan), treatment failure, renal function, resource utilization, and development of antimicrobial resistance in stool flora. CONCLUSIONS. The RIVUR study will provide useful information to clinicians about the risks and benefits of prophylactic antibiotics for children who are diagnosed with vesicoureteral reflux after a first or second urinary tract infection. The data and specimens collected over the course of the study will allow researchers to better understand the pathophysiology of recurrent urinary tract infection and its sequelae.

Original languageEnglish (US)
JournalPediatrics
Volume122
Issue numberSUPPL. 5
DOIs
StatePublished - Dec 2008
Externally publishedYes

Fingerprint

Vesico-Ureteral Reflux
Urinary Tract Infections
Cicatrix
Kidney
Sulfamethoxazole Drug Combination Trimethoprim
Placebos
Succimer
North America
Treatment Failure
Renal Insufficiency
Molecular Biology
Primary Health Care
Fever
Randomized Controlled Trials
Research Personnel
Clinical Trials
Urine
Interviews
Anti-Bacterial Agents
Recurrence

Keywords

  • Antimicrobial prophylaxis
  • Controlled trial
  • Randomized
  • Renal scarring
  • Urinary tract infection
  • Vesicoureteral reflux

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Keren, R., Carpenter, M. A., Hoberman, A., Shaikh, N., Matoo, T. K., Chesney, R. W., ... Nyberg, L. (2008). Rationale and design issues of the randomized intervention for children with vesicoureteral reflux (RIVUR) study. Pediatrics, 122(SUPPL. 5). https://doi.org/10.1542/peds.2008-1285d

Rationale and design issues of the randomized intervention for children with vesicoureteral reflux (RIVUR) study. / Keren, Ron; Carpenter, Myra A.; Hoberman, Alejandro; Shaikh, Nader; Matoo, Tej K.; Chesney, Russell W.; Matthews, Ranjiv; Gerson, Arlene C.; Greenfield, Saul P.; Fivush, Barbara A; McLurie, Gordon A.; Rushton, H. Gil; Canning, Douglas; Nelson, Caleb P.; Greenbaum, Lawrence; Bukowski, Timothy; Primack, William; Sutherland, Richard; Hosking, James; Stewart, Dawn; Elder, Jack; Moxey-Mims, Marva; Nyberg, Leroy.

In: Pediatrics, Vol. 122, No. SUPPL. 5, 12.2008.

Research output: Contribution to journalArticle

Keren, R, Carpenter, MA, Hoberman, A, Shaikh, N, Matoo, TK, Chesney, RW, Matthews, R, Gerson, AC, Greenfield, SP, Fivush, BA, 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 2008, 'Rationale and design issues of the randomized intervention for children with vesicoureteral reflux (RIVUR) study', Pediatrics, vol. 122, no. SUPPL. 5. https://doi.org/10.1542/peds.2008-1285d
Keren, Ron ; Carpenter, Myra A. ; Hoberman, Alejandro ; Shaikh, Nader ; Matoo, Tej K. ; Chesney, Russell W. ; Matthews, Ranjiv ; Gerson, Arlene C. ; Greenfield, Saul P. ; Fivush, Barbara A ; McLurie, Gordon A. ; Rushton, H. Gil ; Canning, Douglas ; Nelson, Caleb P. ; Greenbaum, Lawrence ; Bukowski, Timothy ; Primack, William ; Sutherland, Richard ; Hosking, James ; Stewart, Dawn ; Elder, Jack ; Moxey-Mims, Marva ; Nyberg, Leroy. / Rationale and design issues of the randomized intervention for children with vesicoureteral reflux (RIVUR) study. In: Pediatrics. 2008 ; Vol. 122, No. SUPPL. 5.
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T1 - Rationale and design issues of the randomized intervention for children with vesicoureteral reflux (RIVUR) study

AU - Keren, Ron

AU - Carpenter, Myra A.

AU - Hoberman, Alejandro

AU - Shaikh, Nader

AU - Matoo, Tej K.

AU - Chesney, Russell W.

AU - Matthews, Ranjiv

AU - Gerson, Arlene C.

AU - Greenfield, Saul P.

AU - Fivush, Barbara A

AU - McLurie, Gordon A.

AU - Rushton, H. Gil

AU - Canning, Douglas

AU - Nelson, Caleb P.

AU - Greenbaum, Lawrence

AU - Bukowski, Timothy

AU - Primack, William

AU - Sutherland, Richard

AU - Hosking, James

AU - Stewart, Dawn

AU - Elder, Jack

AU - Moxey-Mims, Marva

AU - Nyberg, Leroy

PY - 2008/12

Y1 - 2008/12

N2 - OBJECTIVE. Our goal is to determine if antimicrobial prophylaxis with trimethoprim/sulfamethoxazole prevents recurrent urinary tract infections and renal scarring in children who are found to have vesicoureteral reflux after a first or second urinary tract infection. DESIGN, PARTICIPANTS, AND METHODS. The Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) study is a double-blind, randomized, placebo-controlled trial. Six hundred children aged 2 to 72 months will be recruited from both primary and subspecialty care settings at clinical trial centers throughout North America. Children who are found to have grades I to IV vesicoureteral reflux after the index febrile or symptomatic urinary tract infection will be randomly assigned to receive daily doses of either trimethoprim/sulfamethoxazole or placebo for 2 years. Scheduled follow-up contacts include in-person study visits every 6 months and telephone interviews every 2 months. Biospecimens (urine and blood) and genetic specimens (blood) will be collected for future studies of the genetic and biochemical determinants of vesicoureteral reflux, recurrent urinary tract infection, renal insufficiency, and renal scarring. RESULTS. The primary outcome is recurrence of urinary tract infection. Secondary outcomes include time to recurrent urinary tract infection, renal scarring (assessed by dimercaptosuccinic acid scan), treatment failure, renal function, resource utilization, and development of antimicrobial resistance in stool flora. CONCLUSIONS. The RIVUR study will provide useful information to clinicians about the risks and benefits of prophylactic antibiotics for children who are diagnosed with vesicoureteral reflux after a first or second urinary tract infection. The data and specimens collected over the course of the study will allow researchers to better understand the pathophysiology of recurrent urinary tract infection and its sequelae.

AB - OBJECTIVE. Our goal is to determine if antimicrobial prophylaxis with trimethoprim/sulfamethoxazole prevents recurrent urinary tract infections and renal scarring in children who are found to have vesicoureteral reflux after a first or second urinary tract infection. DESIGN, PARTICIPANTS, AND METHODS. The Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) study is a double-blind, randomized, placebo-controlled trial. Six hundred children aged 2 to 72 months will be recruited from both primary and subspecialty care settings at clinical trial centers throughout North America. Children who are found to have grades I to IV vesicoureteral reflux after the index febrile or symptomatic urinary tract infection will be randomly assigned to receive daily doses of either trimethoprim/sulfamethoxazole or placebo for 2 years. Scheduled follow-up contacts include in-person study visits every 6 months and telephone interviews every 2 months. Biospecimens (urine and blood) and genetic specimens (blood) will be collected for future studies of the genetic and biochemical determinants of vesicoureteral reflux, recurrent urinary tract infection, renal insufficiency, and renal scarring. RESULTS. The primary outcome is recurrence of urinary tract infection. Secondary outcomes include time to recurrent urinary tract infection, renal scarring (assessed by dimercaptosuccinic acid scan), treatment failure, renal function, resource utilization, and development of antimicrobial resistance in stool flora. CONCLUSIONS. The RIVUR study will provide useful information to clinicians about the risks and benefits of prophylactic antibiotics for children who are diagnosed with vesicoureteral reflux after a first or second urinary tract infection. The data and specimens collected over the course of the study will allow researchers to better understand the pathophysiology of recurrent urinary tract infection and its sequelae.

KW - Antimicrobial prophylaxis

KW - Controlled trial

KW - Randomized

KW - Renal scarring

KW - Urinary tract infection

KW - Vesicoureteral reflux

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