Sisomicin — efficacy and tolerance of various dosages in urinary tract infections

Abstract

Sisomicin was administered in three studies to a total of 65 hospitalized patients with complicated genitourinary conditions. Study 1 consisted of 20 hospitalized patients who received intramuscular injections of 1.0 mg/kg for seven to ten days. Study 2 was a comparison of once daily versus twice daily administration of 24 patients. The dose was 75 mg or 100 mg once or twice daily, depending on weight. In study 3, an ongoing study, the effectiveness and tolerance of sisomicin administered in a BID regimen versus gentamicin in the conventional TID regimen were compared. The dose of sisomicin was 50 mg or 75 mg BID depending on patients' weight, and that of gentamicin was 60 mg or 80 mg TID, depending on weight. Urine cultures were done on all patients prior, during, and after treatment. If possible, vestibular function and hearing were checked each day. Hematological and blood chemistry tests, including tests of renal and hepatic function, were usually done once before, and three times during, treatment. Sisomicin serum levels were assayed by obtaining blood samples one hour after injection on various days during treatment. In study 1 18 of 20 infections were evaluated as resolved both clinically and bacteriologically at the end of the treatment period. In study 2 the infections of ten of the 12 patients who were treated on the once-daily regimen were considered clinically and bacteriologically resolved. Nine of the 12 patients treated BID with sisomicin were clinically and bacteriologically cured. In study 3 all seven patients receiving sisomicin BID were clinically and bacteriologically cured. Five of the 14 patients treated with gentamicin TID were clinically and bacteriologically cured. Local tolerance was good in all patients except for two in study 1 who experienced moderate pain. There was one probable adverse reaction, a rise in creatinine clearance in a patient in study 3 treated with gentamicin. All other laboratory values and clinical observations were within normal limits.