Comparative clinical trial of sisomicin and gentamicin in serious systemic gram-negative infections.

One hundred one hospitalized patients with serious gram-negative infections were treated with either sisomicin, 1.0 mg/kg every eight hours, or gentamicin, 1.5 mg/kg every eight hours, in a multicenter study conducted at ten separate locations in the United States. Since the drugs were administered at different dosages, a blinded investigator was employed to assess treatment response, while an unblinded investigator was responsible for making dosage adjustments based on each patient's renal function and clinical response. Sixty of the patients (sisomicin, 29; gentamicin, 31) were treated for a sufficient period (average seven to ten days) to be valid for inclusion in the assessment of treatment efficacy; 81 were included in the safety analysis. Sisomicin was found to be superior to gentamicin in bacteriological response and slightly better than gentamicin in producing favorable clinical responses. Elimination of pathogens or a significant reduction in pathogen population was observed in 93% of the sisomicin-treated patients, compared with 67% in the gentamicin group (P = 0.06). The incidence of adverse effects in both treatment groups was low, with no significant differences in adverse reaction patterns.