title: 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.affiliation: Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India, pankajhari@hotmail.com.
authors.forename: Pankaj
authors.initials: P
authors.lastname: Hari
authors.forename: Smriti
authors.initials: S
authors.lastname: Hari
authors.forename: Aditi
authors.initials: A
authors.lastname: Sinha
authors.forename: Rakesh
authors.initials: R
authors.lastname: Kumar
authors.forename: Arti
authors.initials: A
authors.lastname: Kapil
authors.forename: Ravindra Mohan
authors.initials: RM
authors.lastname: Pandey
authors.forename: Arvind
authors.initials: A
authors.lastname: Bagga
mesh_terms: D000892:Anti-Infective Agents, Urinary / Q000627:therapeutic use*; D018890:Chemoprevention; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000627:therapeutic use*; D014552:Urinary Tract Infections / Q000209:etiology* / Q000517:prevention & control*; D014718:Vesico-Ureteral Reflux / Q000150:complications*
chemical_list: D000892:Anti-Infective Agents, Urinary; D015662:Trimethoprim, Sulfamethoxazole Drug Combination