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EDITORIALS: Jonathan C Craig and Elisabeth M Hodson Treatment of acute pyelonephritis in children BMJ 2004; 328: 179-180 [Full text]

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Are oral and intravenous antibiotics for children with pyelonepritis really equivalent? Caution needed

Juan M. Lozano   (30 January 2004)

Are oral and intravenous antibiotics for children with pyelonepritis really equivalent? Caution needed 30 January 2004
Juan M. Lozano, Professor of Paediatrics and Clinical Epidemiology School of Medicine, Pontificia Universidad Javeriana. Carrera 7 No. 40-62, Bogotá, Colombia Send response to journal: Re: Are oral and intravenous antibiotics for children with pyelonepritis really equivalent? Caution needed	I read with great interest the editorial on treatment of acute pyelonephritis in children by Craig and Hodson (1). I believe, however, that the evidence supporting one of their major conclusions (i.e., that oral and intravenous antibiotics are equally safe and effective) has important caveats. None of the two trials (one published (2), one ongoing (3)) comparing oral and parenteral antibiotics have found statistically significant differences in the frequency of renal scars after six months to one year of follow-up. However, they were not specifically designed to assess whether the two treatments were indeed equivalent. Rather, they aimed to determine if there were differences between them. Although well established, it is often poorly recognized that failing to demonstrate differences in a randomised controlled trial does not mean that they are equivalent (4,5). The largest study, conducted by Hoberman et al. (2), illustrates the issue. Renal scarring was found in 11 out of 140 and in 15 out of 132 children assessed 6 months after treatment and who had been treated with intravenous cefotaxime or with oral cefixime, respectively. The absolute rate difference in the frequency of this outcome is -3.5%; however, its 95% confidence interval (-10.9% to 3.6%) shows that the rate with oral therapy could be almost 11% higher than that observed with parenteral therapy. In other words, the evidence suggest that the treatments could be equivalent but does not allow (yet) ruling-out clinically important differences. I believe that Craig and Hodson should be more cautious in their conclusions. It is necessary to conduct a well designed equivalence randomized trial before recommending oral antibiotics as an alternative to parenteral treatment in children with acute pyelonephritis. Juan Manuel Lozano, MD, MSc References 1. Craig JC, Hodson EM. Treatment of acute pyelonephritis in children. MJ 2004;328: 179-180 2. Hoberman A, Wald ER, Hickey R, Baskin M, Charron M, Majd M, et al. Oral versus initial intravenous therapy for urinary tract infections in young febrile children. Pediatrics 1999; 104:79-86 3. Montini G, Murer L, Gobber D, Comacchio S, Toffolo A, Dall'Amico R, et al, on behalf of the IRIS Study Group. Oral vs initial intravenous antibiotic treatment of urinary tract infections in children: a multicentre trial. Nephrol Dial Transpl 2003;18(suppl 4): 816a 4. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ 1996;313: 36-9 5. Makuch RW, Johnson MF. Some issues in the design and interpretation of “negative” studies. Arch Int Med 1986;146: 986-9 Competing interests: None declared