International Journal of Antimicrobial Agents 14 (2000) 51 – 55 Original article Isepamicin versus amikacin for the treatment of acute pyelonephritis in children D.A. Kafetzis a, *, H.C. Maltezou a , M. Mavrikou b , C. Siafas b , I. Paraskakis c , D. Delis b , C. Bartsokas b a Second Department of Pediatrics, Uniersity of Athens, P. and A. Kyriakou Children’s Hospital, Athens 11527, Greece b First Department of Pediatrics, P. and A. Kyriakou Children’s Hospital, Athens 11527, Greece c Department of Microbiology, P. and A. Kyriakou Chlidren’s Hospital, Athens 11527, Greece Received 5 August 1999; accepted 23 September 1999 Abstract In this study we compared the efficacy and safety of isepamicin versus amikacin at a dose of 7.5 mg/kg i.v. q12h for 10–14 days in children with pyelonephritis. Sixteen children were enrolled in the study; ten received isepamicin and six amikacin. Urine cultures grew Escherichia coli in all patients. All patients were treated successfully with either isepamicin or amikacin. Clinical and bacteriological response rates were 100% for both groups. No adverse events occurred. Peak serum levels ranged from 9.05 to 30.70 mg/l (median: 16.165) and from 12.20 to 25.90 mg/l (median: 19.05) for isepamicin and amikacin, respectively. Trough serum levels ranged from 0.11 to 3.20 mg/l (median: 0.75) and from 0.1 to 2.1 mg/l (median: 0.655), respectively. Isepamicin was shown to be as effective and safe as amikacin in the treatment of children with pyelonephritis and might prove an advantageous alternative in areas with high incidence of resistance to other aminoglycosides. © 2000 Elsevier Science B.V. and International Society of Chemotherapy. All rights reserved. Keywords: Isepamicin; Pyelonephritis; Children www.ischemo.org 1. Introduction During the last 15 years, several epidemiological studies of nosocomial bacteria have shown a trend towards the understanding of complex aminoglycoside- resistance mechanisms including inactivating enzymes that acetylate, adenylate or phosphorylate aminogly- cosides as well as modification of the bacterial wall permeability to these agents. These resistance patterns show a specific geographic distribution and predomi- nantly concern nosocomial strains [1]. The introduction of an efficacious alternative in areas with a high preva- lence of resistance would be most useful. Isepamicin, a new gentamicin-B derivative that was first described by Nagabhushan et al. [2], demonstrates comparable antimicrobial potency, spectrum and phar- macokinetics to amikacin [1] but possesses a unique stability to aminoglycoside-inactivating enzymes [1,3]. Clinical studies have shown that isepamicin is as effec- tive and safe as amikacin in the treatment of adult patients with urinary tract infections and neutropenic and non-neutropenic paediatric patients with various infections [4,5]. To our knowledge, there are no studies reporting the efficacy of isepamicin in children with acute pyelonephritis. The objective of this study was to compare the efficacy and safety of isepamicin with amikacin in the treatment of paediatric patients with acute pyelonephritis and to compare blood levels in paediatric patients after administration of the same dosage. * Corresponding author. Tel.: +30-1-772-6349; fax: +30-1-674- 3381. E-mail address: kafetzis@ath.forthnet.gr (D.A. Kafetzis) 0924-8579/00/$20 © 2000 Elsevier Science B.V. and International Society of Chemotherapy. All rights reserved. PII:S0924-8579(99)00138-7