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original article

Antibiotic Prophylaxis and Recurrent Urinary Tract Infection in Children
Jonathan C. Craig, M.B., Ch.B., Ph.D., Judy M. Simpson, Ph.D., Gabrielle J. Williams, Ph.D., M.P.H., Alison Lowe, B.Sc., Graham J. Reynolds, M.B., B.S., Steven J. McTaggart, M.B., B.S., Ph.D., Elisabeth M. Hodson, M.B., B.S., Jonathan R.Carapetis, M.B., B.S., Ph.D., Noel E. Cranswick, M.B., B.S., Grahame Smith, M.B., B.S., Les M. Irwig, M.B., B.Ch., Ph.D., Patrina H.Y. Caldwell, Ph.D., Sana Hamilton, M.P.H., and Leslie P. Roy, M.B., B.S., for the Prevention of Recurrent Urinary Tract Infection in Children with Vesicoureteric Reflux and Normal Renal Tracts (PRIVENT) Investigators

A bs t r ac t
Background
From the Screening andTest Evaluation Program (J.C.C., G.J.W., L.M.I.) and the School of Public Health, (J.C.C., J.M.S., E.M.H., L.M.I.), University of Sydney; the Centre for Kidney Research, Children’s Hospital at Westmead (J.C.C., G.J.W., A.L., E.M.H., P.H.Y.C., S.H., L.P.R.); and the Department of Urology and Surgery, Children’s Hospital at Westmead (G.S.) — all in Sydney; the Department of Paediatrics and ChildHealth, Australian National University Medical School, Canberra (G.J.R.); Queensland Child and Adolescent Renal Service and the University of Queensland, Brisbane (S.J.M.); Menzies School of Health Research, Charles Darwin University, Darwin (J.R.C.); and Murdoch Children’s Research Institute and Royal Children’s Hospital, University of Melbourne, Melbourne (N.E.C.) — all in Australia. Addressreprint requests to Dr. Craig at the Children’s Hospital at Westmead, Centre for Kidney Research, Locked Bag 4001, Westmead, Sydney NSW 2145, Australia. This article (10.1056/NEJMoa0902295) was updated on March 31, 2010, at NEJM.org. N Engl J Med 2009;361:1748-59.
Copyright © 2009 Massachusetts Medical Society.

Antibiotics are widely administered to children with the intention of preventing urinarytract infection, but adequately powered, placebo-controlled trials regarding efficacy are lacking. This study from four Australian centers examined whether low-dose, continuous oral antibiotic therapy prevents urinary tract infection in predisposed children.
Methods

We randomly assigned children under the age of 18 years who had had one or more microbiologically proven urinary tract infectionsto receive either daily trimethoprim– sulfamethoxazole suspension (as 2 mg of trimethoprim plus 10 mg of sulfamethoxazole per kilogram of body weight) or placebo for 12 months. The primary outcome was microbiologically confirmed symptomatic urinary tract infection. Intention-totreat analyses were performed with the use of time-to-event data.
Results

From December 1998 to March 2007, a totalof 576 children (of 780 planned) underwent randomization. The median age at entry was 14 months; 64% of the patients were girls, 42% had known vesicoureteral reflux (at least grade III in 53% of these patients), and 71% were enrolled after the first diagnosis of urinary tract infection. During the study, urinary tract infection developed in 36 of 288 patients (13%) in the group receivingtrimethoprim–sulfamethoxazole (antibiotic group) and in 55 of 288 patients (19%) in the placebo group (hazard ratio in the antibiotic group, 0.61; 95% confidence interval, 0.40 to 0.93; P = 0.02 by the log-rank test). In the antibiotic group, the reduction in the absolute risk of urinary tract infection (6 percentage points) appeared to be consistent across all subgroups of patients (P≥0.20 for allinteractions).
Conclusions

Long-term, low-dose trimethoprim–sulfamethoxazole was associated with a decreased number of urinary tract infections in predisposed children. The treatment effect appeared to be consistent but modest across subgroups. (Australian New Zealand Clinical Trials Registry number, ACTRN12608000470392.)
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n engl j med 361;18 nejm.org october 29, 2009

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