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 Fivush; Gordon A. McLurie; H. Gil Rushton; Douglas Canning; Caleb P. Nelson; Lawrence Greenbaum; Timothy Bukowski; William Primack; Richard Sutherland; James Hosking; Dawn Stewart; Jack Elder; Marva Moxey-Mims; Leroy Nyberg

doi:10.1542/peds.2008-1285d

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 Fivush, Gordon A. McLurie, H. Gil Rushton, Douglas Canning, Caleb P. Nelson, Lawrence Greenbaum, Timothy Bukowski, William Primack, Richard Sutherland, James Hosking, Dawn StewartJack Elder, Marva Moxey-Mims, Leroy Nyberg

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81 Scopus citations

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 language	English (US)
Pages (from-to)	S240-S250
Journal	Pediatrics
Volume	122
Issue number	SUPPL. 5
DOIs	https://doi.org/10.1542/peds.2008-1285d
State	Published - Dec 2008
Externally published	Yes

Keywords

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

ASJC Scopus subject areas

Pediatrics, Perinatology, and Child Health

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10.1542/peds.2008-1285d

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Keren, R., Carpenter, M. A., Hoberman, A., Shaikh, N., Matoo, T. K., Chesney, R. W., Matthews, R., Gerson, A. C., Greenfield, S. P., Fivush, B., McLurie, G. A., Rushton, H. G., Canning, D., Nelson, C. P., Greenbaum, L., Bukowski, T., Primack, W., Sutherland, R., Hosking, J., ... Nyberg, L. (2008). Rationale and design issues of the randomized intervention for children with vesicoureteral reflux (RIVUR) study. Pediatrics, 122(SUPPL. 5), S240-S250. https://doi.org/10.1542/peds.2008-1285d

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 2008, 'Rationale and design issues of the randomized intervention for children with vesicoureteral reflux (RIVUR) study', Pediatrics, vol. 122, no. SUPPL. 5, pp. S240-S250. https://doi.org/10.1542/peds.2008-1285d

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

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.",

keywords = "Antimicrobial prophylaxis, Controlled trial, Randomized, Renal scarring, Urinary tract infection, Vesicoureteral reflux",

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

year = "2008",

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doi = "10.1542/peds.2008-1285d",

language = "English (US)",

volume = "122",

pages = "S240--S250",

journal = "Pediatrics",

issn = "0031-4005",

publisher = "American Academy of Pediatrics",

number = "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

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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DO - 10.1542/peds.2008-1285d

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AN - SCOPUS:58149379282

SN - 0031-4005

VL - 122

SP - S240-S250

JO - Pediatrics

JF - Pediatrics

IS - SUPPL. 5

ER -

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

Abstract

Keywords

ASJC Scopus subject areas

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