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.
|Number of pages||7|
|Journal||Journal of Chemotherapy|
|Issue number||SUPPL. 2|
|Publication status||Published - 1995|
ASJC Scopus subject areas
- Microbiology (medical)
- Pharmacology (medical)