In a series of three prospective, randomised, multicentre trials, isep
amicin (15 mg/kg or 8 mg/kg once daily depending on severity of infect
ion) was compared with amikacin (7.5 mg/kg twice daily) in a total of
252 adult hospitalised patients (mean age 51-54 years) with urinary tr
act infection. Pretreatment pathogens included Escherichia coli, which
was isolated from approximately 50% of patients, and Pseudomonas aeru
ginosa, which was isolated from approximately 10% of patients with sev
ere infections. The most commonly occurring primary diagnoses were com
plicated pyelonephritis, uncomplicated pyelonephritis and complicated
lower urinary tract infection. For the patients included in the effica
cy population, elimination of the pathogens occurred, for all infectio
ns combined, in 92/101 (91%) patients in the isepamicin group and 51/5
5 (93%) patients in the amikacin group. Adverse events occurred in 15%
of isepamicin patients and 6% of amikacin patients. Ototoxicity at th
e greater than or equal to 20 dB threshold was noted in one isepamicin
and two amikacin patients, but none of these patients had associated
clinical signs of auditory or vestibular toxicity. Four isepamicin and
four amikacin patients had potentially significant increases in serum
creatinine indicative of possible nephrotoxicity.