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Previous Volume 361:1748-1759 October 29, 2009 Number 18 Next

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ABSTRACT

Background Antibiotics are widely administered to children with the intention of preventing urinary tract 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 infections to 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-to-treat analyses were performed with the use of time-to-event data.

Results From December 1998 to March 2007, a total of 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 receiving trimethoprim–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 (P0.20 for all interactions).

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.)

Source Information

From the Screening and Test 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 Child Health, 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.

Address reprint requests to Dr. Craig at the Children's Hospital at Westmead, Centre for Kidney Research, Locked Bag 4001, Westmead, Sydney NSW 2145, Australia.

Full Text of this Article

This article has been cited by other articles:

• (2009). All you need to read in the other general journals. BMJ 339: b4534-b4534 [Full Text]  
• Hoberman, A., Keren, R. (2009). Antimicrobial Prophylaxis for Urinary Tract Infection in Children. NEJM 361: 1804-1806 [Full Text]  
• (2009). Antibiotic Prophylaxis for Children with UTIs. JWatch Pediatrics 2009: 1-1 [Full Text]