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

Keren, R and Carpenter, MA and Hoberman, A and Shaikh, N and Matoo, TK and Chesney, RW and Matthews, R and Gerson, AC and Greenfield, SP and Fivush, B and McLurie, GA and Rushton, HG and Canning, D and Nelson, CP and Greenbaum, L and Bukowski, T and Primack, W and Sutherland, R and Hosking, J and Stewart, D and Elder, J and Moxey-Mims, M and Nyberg, L (2008) Rationale and design issues of the randomized intervention for children with vesicoureteral reflux (RIVUR) study. Pediatrics, 122 (SUPPL.). ISSN 0031-4005

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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. Copyright © 2008 by the American Academy of Pediatrics.


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Item Type: Article
Status: Published
CreatorsEmailPitt UsernameORCID
Keren, R
Carpenter, MA
Hoberman, Aalejo@pitt.eduALEJO
Shaikh, Nnas67@pitt.eduNAS67
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
Date: 1 December 2008
Date Type: Publication
Journal or Publication Title: Pediatrics
Volume: 122
Number: SUPPL.
DOI or Unique Handle: 10.1542/peds.2008-1285d
Schools and Programs: School of Public Health > Biostatistics
School of Medicine > Pediatrics
Refereed: Yes
ISSN: 0031-4005
MeSH Headings: Anti-Bacterial Agents--administration & dosage; Anti-Bacterial Agents--therapeutic use; Child; Child, Preschool; Cicatrix--etiology; Cicatrix--prevention & control; Clinical Protocols; Double-Blind Method; Drug Administration Schedule; Early Diagnosis; Female; Follow-Up Studies; Humans; Infant; Kidney--pathology; Kidney--ultrasonography; Male; Pyelonephritis--pathology; Pyelonephritis--prevention & control; Recurrence; Research Design; Unnecessary Procedures; Urinary Tract Infections--diagnosis; Urinary Tract Infections--drug therapy; Urinary Tract Infections--etiology; Urinary Tract Infections--pathology; Urinary Tract Infections--prevention & control; Vesico-Ureteral Reflux--complications
Other ID: NLM NIHMS182752, NLM PMC2842127
PubMed Central ID: PMC2842127
PubMed ID: 19018048
Date Deposited: 10 Sep 2012 14:45
Last Modified: 04 Jul 2023 10:55


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