The efficacy of once-daily administration of
isepamicin in hospitalized adult patients has been assessed in a multinational clinical trails programme. Following a small phase II programme, the phase III programmed assessed four main indications: lower
respiratory tract infections (including
nosocomial pneumonia), urinary tract, intra-abdominal and skin and
soft tissue infections. The phase III trials were open, prospective, multicentre studies in which 1443 patients were randomised to receive either
isepamicin (n = 1005) or
amikacin (n = 438). The daily dose of
isepamicin was dependent on the severity of
infection (8 or 15 mg/kg once daily) while all patients received
amikacin 7.5 mg/kg twice daily. A study of patients with
nosocomial pneumonia had an additional treatment arm of
isepamicin 7.5 mg/kg twice daily. The
aminoglycosides were combined with other
antimicrobial agents in accordance with current clinical practice depending on the site and severity of the
infection and the type of organism isolated. Overall, clinical cure or improvement response rates of the
isepamicin and
amikacin regimens were comparable, ranging from 76-95% in the intent-to-treat population. Lower clinical response rates (62-63%) was observed in severely ill patients with
nosocomial pneumonia in both the
isepamicin and
amikacin treatment groups. In the efficacy population, organism elimination rates of 90% were achieved with
isepamicin and
amikacin. Therefore, in adult patients with a wide range of
infections requiring
aminoglycoside therapy, once-daily dosing with
isepamicin is as effective as twice- daily dosing with
amikacin.