Isepamicin versus amikacin in the treatment of urinary tract infection.

In a series of three prospective, randomised, multicentre trials, isepamicin (15 mg/kg or 8 mg/kg once daily depending on severity of infection) was compared with amikacin (7.5 mg/kg twice daily) in a total 252 adult hospitalised patients (mean age 51-54 years) with urinary tract infection. Pretreatment pathogens included Escherichia coli, which was isolated from approximately 50% of patients, and Pseudomonas aeruginosa, which was isolated from approximately 10% of patients with severe infections. The most commonly occurring primary diagnoses were complicated pyelonephritis, uncomplicated pyelonephritis and complicated lower urinary tract infection. For the patients included in the efficacy population, elimination of the pathogens occurred for all infections combined, in 92/101 (91%) patients in the isepamicin group and 51/55 (93%) patients in the amikacin group. Adverse events occurred in 15% of isepamicin patients and 6% of amikacin patients. Ototoxicity at the > or = 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.