BACKGROUND:Children with febrile urinary tract infection commonly have vesicoureteral reflux. Because trial results have been limited and inconsistent, the use of antimicrobial prophylaxis to prevent recurrences in children with reflux remains controversial. METHODS: 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 infection, we evaluated the efficacy of trimethoprim-sulfamethoxazole prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance. RESULTS:Recurrent urinary tract infection developed in 39 of 302 children who received prophylaxis as compared with 72 of 305 children who received placebo (relative risk, 0.55; 95% confidence interval [CI], 0.38 to 0.78). Prophylaxis reduced the risk of recurrences by 50% (hazard ratio, 0.50; 95% CI, 0.34 to 0.74) and was particularly effective in children whose index infection was febrile (hazard ratio, 0.41; 95% CI, 0.26 to 0.64) and in those with baseline bladder and bowel dysfunction (hazard ratio, 0.21; 95% CI, 0.08 to 0.58). The occurrence of renal scarring did not differ significantly between the prophylaxis and placebo groups (11.9% and 10.2%, respectively). Among 87 children with a first recurrence caused by Escherichia coli, the proportion of isolates that were resistant to trimethoprim-sulfamethoxazole was 63% in the prophylaxis group and 19% in the placebo group. CONCLUSIONS: Among children with vesicoureteral reflux after urinary tract infection, antimicrobial prophylaxis was associated with a substantially reduced risk of recurrence but not of renal scarring. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; RIVUR ClinicalTrials.gov number, NCT00405704.).
RCT Entities:
BACKGROUND:Children with febrile urinary tract infection commonly have vesicoureteral reflux. Because trial results have been limited and inconsistent, the use of antimicrobial prophylaxis to prevent recurrences in children with reflux remains controversial. METHODS: 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 infection, we evaluated the efficacy of trimethoprim-sulfamethoxazole prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance. RESULTS: Recurrent urinary tract infection developed in 39 of 302 children who received prophylaxis as compared with 72 of 305 children who received placebo (relative risk, 0.55; 95% confidence interval [CI], 0.38 to 0.78). Prophylaxis reduced the risk of recurrences by 50% (hazard ratio, 0.50; 95% CI, 0.34 to 0.74) and was particularly effective in children whose index infection was febrile (hazard ratio, 0.41; 95% CI, 0.26 to 0.64) and in those with baseline bladder and bowel dysfunction (hazard ratio, 0.21; 95% CI, 0.08 to 0.58). The occurrence of renal scarring did not differ significantly between the prophylaxis and placebo groups (11.9% and 10.2%, respectively). Among 87 children with a first recurrence caused by Escherichia coli, the proportion of isolates that were resistant to trimethoprim-sulfamethoxazole was 63% in the prophylaxis group and 19% in the placebo group. CONCLUSIONS: Among children with vesicoureteral reflux after urinary tract infection, antimicrobial prophylaxis was associated with a substantially reduced risk of recurrence but not of renal scarring. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; RIVUR ClinicalTrials.gov number, NCT00405704.).
Authors: Jonathan C Craig; Judy M Simpson; Gabrielle J Williams; Alison Lowe; Graham J Reynolds; Steven J McTaggart; Elisabeth M Hodson; Jonathan R Carapetis; Noel E Cranswick; Grahame Smith; Les M Irwig; Patrina H Y Caldwell; Sana Hamilton; Leslie P Roy Journal: N Engl J Med Date: 2009-10-29 Impact factor: 91.245
Authors: 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 Journal: Pediatrics Date: 2008-12 Impact factor: 7.124
Authors: Russell W Chesney; Myra A Carpenter; Marva Moxey-Mims; Leroy Nyberg; Saul P Greenfield; Alejandro Hoberman; Ron Keren; Ron Matthews; Tej K Matoo Journal: Pediatrics Date: 2008-12 Impact factor: 7.124
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Authors: Tej K Mattoo; Steven J Skoog; Lisa Gravens-Mueller; Russell W Chesney; Alejandro Hoberman; Ranjiv Mathews; Marva Moxey-Mims; Anastasia Ivanova; Saul P Greenfield; Myra A Carpenter Journal: J Pediatr Urol Date: 2017-06-01 Impact factor: 1.830
Authors: Rachel E Selekman; Daniel J Shapiro; John Boscardin; Gabrielle Williams; Jonathan C Craig; Per Brandström; Marco Pennesi; Gwenalle Roussey-Kesler; Pankaj Hari; Hillary L Copp Journal: Pediatrics Date: 2018-07 Impact factor: 7.124