Pediatric Nephrology

, Volume 30, Issue 3, pp 479–486 | Cite as

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

  • Pankaj HariEmail author
  • Smriti Hari
  • Aditi Sinha
  • Rakesh Kumar
  • Arti Kapil
  • Ravindra Mohan Pandey
  • Arvind Bagga
Original Article



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.


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.


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.


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.


Urinary tract infection Trimethoprim–sulphamethoxazole Asymptomatic bacteriuria Bacterial resistance DMSA scan Renal scar 



The study was funded by the Indian Council of Medical Research.


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Copyright information

© IPNA 2014

Authors and Affiliations

  • Pankaj Hari
    • 1
    Email author
  • Smriti Hari
    • 2
  • Aditi Sinha
    • 1
  • Rakesh Kumar
    • 3
  • Arti Kapil
    • 4
  • Ravindra Mohan Pandey
    • 5
  • Arvind Bagga
    • 1
  1. 1.Department of PediatricsAll India Institute of Medical SciencesAnsari Nagar, New DelhiIndia
  2. 2.Department of RadiodiagnosisAll India Institute of Medical SciencesAnsari Nagar, New DelhiIndia
  3. 3.Department of Nuclear MedicineAll India Institute of Medical SciencesAnsari Nagar, New DelhiIndia
  4. 4.Department of MicrobiologyAll India Institute of Medical SciencesAnsari Nagar, New DelhiIndia
  5. 5.Department of BiostatisticsAll India Institute of Medical SciencesAnsari Nagar, New DelhiIndia

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