A multicentre, non-comparative study evaluated the efficacy and safety of the new
aminoglycoside isepamicin in hospitalised patients with various
infections.
Isepamicin was administered once daily with the daily dosage stratified according to the severity of
infection: 15 mg/kg
isepamicin for severe potentially systemic
infections (53 patients) or 8 mg/kg
isepamicin for less severe and localised
infections (56 patients). The largest groups of patients had
urinary tract infection (n = 54) or lower
respiratory tract infection (n = 31); smaller numbers of patients were enrolled with skin and
soft tissue infections (n = 9),
intra-abdominal infections (n = 8) or obstetric and gynaecological
infections (n = 7). In the patients receiving 15 mg/kg
isepamicin, clinical cure or improvement occurred in 19/21 patients with lower
respiratory tract infections, 8/13 patients with
urinary tract infections, 6/6 patients with skin
infections, 5/6 patients with
intra-abdominal infections and 6/7 patients with obstetric gynaecological
infections. In the patients receiving 8 mg/kg
isepamicin, 40 out of 41 patients with
urinary tract infections were considered cured or improved as were 8/10 patients with lower
respiratory tract infections, 1/3 patients with skin
infections and 1/2 patients with
intra-abdominal infections. Nine per cent of patients reported at least on adverse event during the study. Two patients (one from each dosage group) discontinued treatment because of adverse events, respiratory disorder and erythematous
rash, but neither event was considered to be severe of life threatening No patients had evidence of
ototoxicity by pure-tone audiometry and no patients had potentially significant increases in serum
creatinine which were considered to be treatment related. The results of this study indicate that treatment with
isepamicin once daily is effective and well tolerated in hospitalised adults with various
infections.