Antibiotic prophylaxis in the management of vesicoureteric reflux: a randomized double-blind placebo-controlled trial.

Abstract

BACKGROUND:

The benefits of long-term low-dose antibiotics in preventing urinary tract infection (UTI) and renal damage in children with primary vesicoureteric reflux (VUR) are unclear.

METHODS:

Children aged between 1 and 12 years with VUR grade I-IV and a microbiologically proven UTI were randomized into two groups to receive either antibiotic prophylaxis [2 mg/kg trimethoprim + sulfamethoxazole (TMP-SMX)] daily or placebo, respectively, for 12 months. Primary outcome was microbiologically confirmed symptomatic UTI. Intention-to-treat analysis using time-to-event data was performed.

RESULTS:

A total of 93 children (66.7 % boys) with a median age of 4.6 years were enrolled in this study; VUR grade III-IV was present in 73.1 % of these children. At least one symptomatic UTI occurred in ten (21.3 %) patients receiving antibiotic prophylaxis and in three (6.5 %) patients receiving placebo [hazard ratio in antibiotic group 3.9; 95 % confidence interval (CI) 1- 14; log rank test P = 0.02). Compared to the group receiving placebo, the antibiotic group had a 14.8 % increased risk for developing UTI (95 % CI 1-28; P = 0.03). Of the total number of episodes of UTI, 58.3 % of those in the antibiotic group were caused by TMP-SMX-resistant bacteria compared to 20 % in the placebo group (P = 0.15). A renal scan at 12 months revealed that six of 37 (16.2 %) patients in the antibiotic group and seven of 43 (16.3 %) patients in the placebo group had new or worsening of pre-existing scar.

CONCLUSIONS:

Long-term antibiotic prophylaxis with TMP-SMX is associated with increased risk of symptomatic UTI compared to placebo in children with grade I-IV VUR.

• Authors: Pankaj Hari, Smriti Hari, Aditi Sinha, Rakesh Kumar, Arti Kapil, Ravindra Mohan Pandey, Arvind Bagga
• Journal: Pediatric nephrology (Berlin, Germany) (Pediatr Nephrol) Vol. 30 Issue 3 Pg. 479-86 (Mar 2015) ISSN: 1432-198X [Electronic] Germany
• PMID: 25173357 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Infective Agents, Urinary
• Trimethoprim, Sulfamethoxazole Drug Combination

Topics

• Anti-Infective Agents, Urinary (therapeutic use)
• Chemoprevention
• Child
• Child, Preschool
• Double-Blind Method
• Female
• Humans
• Infant
• Male
• Trimethoprim, Sulfamethoxazole Drug Combination (therapeutic use)
• Urinary Tract Infections (etiology, prevention & control)
• Vesico-Ureteral Reflux (complications)