A randomised comparison of isepamicin and amikacin in the treatment of bacterial infections in paediatric patients

A. Vigano, N. Principi

Research output: Contribution to journalArticle


The efficacy and safety of isepamicin 7.5 mg/kg of body weight twice daily or amikacin at the same dosage regimen for the treatment of various infections in neutropenic and non-neutropenic paediatric patients were compared in a prospective randomised trial. In total, 306 patients were enrolled and received at least one dose of randomised treatment (204 isepamicin, 102 amikacin: intent-to-treat population); 181 patients satisfied all criteria for evaluability (120 isepamicin, 61 amikacin: efficacy population). Clinical cure or improvement rates in the isepamicin and amikacin groups were: intent-to-treat population, 188/204 (92%) and 94/102 (92%), respectively; efficacy population, 117/120 (98%) and 58/61 (95%), respectively. The bacteriological elimination rate (efficacy population) in the isepamicin and amikacin treatment groups was 75/76 (99%) vs 35/38 (92%). Nephrotoxicity, defined as an increase in serum creatinine of 0.5 mg/dL or ≥44.2 μmol/L from baseline, occurred in 4/187 (2%) and 1/91 (1%) children treated with isepamicin and amikacin, respectively. Definite ototoxicity at the ≥20 dB threshold occurred in 3 (1 isepamicin and 2 amikacin) out of 56 children evaluated with at least two audiograms. Thus isepamicin was as effective and as well tolerated as amikacin in the treatment of various infections in paediatric patients.

Original languageEnglish
Pages (from-to)95-101
Number of pages7
JournalJournal of Chemotherapy
Issue numberSUPPL. 2
Publication statusPublished - 1995



  • Amikacin
  • Aminoglycoside
  • Isepamicin
  • Paediatrics

ASJC Scopus subject areas

  • Microbiology (medical)
  • Pharmacology (medical)

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