Gli Aminoglicosidi nel Trattamento delle Infezioni Pediatriche: Valutazione del Ruolo di Isepamicina

Summary A large proportion of aerobic Gram-negative organisms, which are responsible for a variety of serious infections especially in hospitalised patients, are susceptible to aminoglycosides. In paediatrics, the clinical situations in which these agents are useful include sepsis and pneumonia in neonates, sepsis in neutropenic patients, respiratory tract infections in patients with cystic fibrosis, endocarditis and urinary tract infections. Isepamicin is a new aminoglycoside antibiotic, which, compared with currently available agents of this class, demonstrates superior stability in the presence of aminoglycoside-inactivating enzymes. A multicentre international study compared the efficacy and safety of isepamicin 7.5 mg/kg twice daily and amikacin at the same dosage regimen in the treatment of various infections in neutropenic and non-neutropenic paediatric patients. A total of 306 patients were enrolled and received treatment (204 isepamicin, 102 amikacin: intention-to-treat population); 181 patients satisfied all criteria for evaluation (120 isepamicin, 61 amikacin: efficacy population). The cure or improvement rates in the isepamicin and amikacin groups were 188/204 (92%) vs 94/102 (92%), respectively, in the intention-to-treat population, and 117/120 (98%) vs 58/61 (95%) in the efficacy population. The bacteriological elimination rates in the isepamicin and amikacin groups were, respectively, 75/76 (99%) vs 35/38 (92%) in the intention-to-treat population (p = 0.083) and 78/98 (79%) vs 37/48 (77%) in the efficacy population. Nephrotoxicity, defined as an increase in serum creatinine of ≥ 0.5 mg/dL or ≥ 44.8 mmol/L from baseline, occurred in 4/187 (2%) and 1/91 (1%) children treated with isepamicin and amikacin respectively. A definite ototoxicity at the ≥ 20dB threshold occurred in 3 (1 isepamicin and 2 amikacin) of 56 children evaluated with at least 2 audiograms. Thus isepamicin appears to be as effective and well tolerated as amikacin in the treatment of various infections in paediatric patients.