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

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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.

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Acknowledgments

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

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Authors and Affiliations

  1. Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India

    Pankaj Hari, Aditi Sinha & Arvind Bagga

  2. Department of Radiodiagnosis, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India

    Smriti Hari

  3. Department of Nuclear Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India

    Rakesh Kumar

  4. Department of Microbiology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India

    Arti Kapil

  5. Department of Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India

    Ravindra Mohan Pandey

Authors
  1. Pankaj Hari
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  2. Smriti Hari
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  3. Aditi Sinha
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  4. Rakesh Kumar
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  5. Arti Kapil
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  6. Ravindra Mohan Pandey
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  7. Arvind Bagga
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Corresponding author

Correspondence to Pankaj Hari.

Additional information

Trial registration

This trial is registered with the Cochrane Renal Group, number CRG110600097

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Hari, P., Hari, S., Sinha, A. et al. Antibiotic prophylaxis in the management of vesicoureteric reflux: a randomized double-blind placebo-controlled trial. Pediatr Nephrol 30, 479–486 (2015). https://doi.org/10.1007/s00467-014-2943-z

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  • DOI: https://doi.org/10.1007/s00467-014-2943-z

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