📃 Paper Title: Antimicrobial prophylaxis for children with vesicoureteral reflux
🧍 Author: RIVUR Trial Investigators
🕒 Year: 2014
📚 Journal: New England Journal of Medicine
🌎 Country: USA
ㅤContext to the study:
Can you tell me about a trial that investigated the role of antibiotic prophylaxis in the management of children with Vesicoureteral Reflux?
ㅤ✅ Take-home message of study:
In children with urinary tract infections due to vesicoureteral reflux (VUR), antibiotic prophylaxis with trimethoprim-sulfamethoxazole compared to placebo:
Reduced the risk of recurrent urinary tract infections. This effect was more evident in children whose index infection was febrile, as well as in those with bladder and bowel dysfunction
Did not reduce the occurrence of renal scarring
Increased resistance of Escherichia coli to trimethoprim-sulfamethoxazole
ㅤ Multisite, randomized, double-blind, placebo-controlled trial
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Study participants:
607 patients with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infection.
Inclusion criteria: Children 2 to 71 months of age with grade I to IV vesicoureteral reflux
Exclusion criteria: Children whose index infection occurred more than 112 days before randomization, children with coexisting urologic anomalies, contraindications for the use of trimethoprim-sulfamethoxazole.
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Key study outcomes:
Mean follow-up: 2 years
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).
The risk of febrile or symptomatic recurrences was reduced by half among children who received prophylaxis as compared with those who received placebo, and the difference between the two groups widened progressively over time (hazard ratio, 0.50; 95% confidence interval [CI], 0.34 to 0.74).
Prophylaxis reduced the risk of recurrences by 50% (hazard ratio, 0.50; 95% CI, 0.34 to 0.74).
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.
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Study Limitations:
Not applicable to children with different demographic or clinical characteristics.
Limited statistical power of some subgroup analyses.
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