[Summarized results of clinical phase II and III studies with ofloxacin (HOE 280) in Europe]

Ofloxacin is a new quinolone-carboxylic acid derivative with a broad spectrum of activity, excellent bioavailability after oral administration and insignificant metabolisation. The serum elimination half-life is six to eight hours. 879 patients were treated with ofloxacin in therapeutic comparative studies monitored by the Department of Clinical Research, Hoechst AG. Of the original isolates 91 to 100% were susceptible to ofloxacin, 67 to 84% to co-trimoxazole, 73 to 98% to a fixed combination of amoxycilline plus clavulanic acid (AMC), 74% to nalidixic acid, 77% to nitrofurantoin, and 79% to pipemidic acid in previous in vitro tests. In the therapeutic studies which included only patients with pathogens susceptible to the antimicrobial agent used, the following cure rates (clinical and bacteriological) were obtained for uncomplicated infections of the lower urinary tract: ofloxacin (single dose treatment) 78% and 83%, co-trimoxazole 62%, nalidixic acid 72%. A three-day course with ofloxacin compared to a three to four-day treatment with co-trimoxazole or seven-day treatment with the other comparative compounds resulted for lower urinary tract infections in the following cure rates: ofloxacin 89%, co-trimoxazole 84%; ofloxacin 71%, AMC 33%; ofloxacin 64%, nitrofurantoin 56%; ofloxacin 56%, pipemidic acid 36%. The unfavourable results after treatment with AMC or pipemidic acid were caused by a high rate of superinfections. The combined cure rate in infections of the upper urinary tract was 73% for ofloxacin and 65% for co-trimoxazole or 81% for ofloxacin and 57% for AMC, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)