title: A randomised comparison of isepamicin and amikacin in the treatment of bacterial infections in paediatric patients.
abstract: The efficacy and safety of isepamicin 7.5 mg/kg of body weight twice daily or amikacin 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 > or = 44.2 mumol/L from baseline, occurred in 4/187 (2%) and 1/191 (1%) children treated with isepamicin and amikacin, respectively. Definite ototoxicity at the > or = 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.
authors.affiliation: Department of Paediatrics, University of Milan, L. Sacco Hospital, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Viganò
authors.forename: N
authors.initials: N
authors.lastname: Principi
mesh_terms: D000293:Adolescent; D000583:Amikacin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D013293:Enterococcus faecalis; D004927:Escherichia coli Infections / Q000188:drug therapy; D005260:Female; D005839:Gentamicins / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007710:Klebsiella Infections / Q000188:drug therapy; D007711:Klebsiella pneumoniae; D008297:Male; D013203:Staphylococcal Infections / Q000188:drug therapy; D013212:Staphylococcus epidermidis; D013290:Streptococcal Infections / Q000188:drug therapy
chemical_list: D000900:Anti-Bacterial Agents; D005839:Gentamicins; D000583:Amikacin; C016927:isepamicin