A STUDY ON THE TREATMENT DURATION OF AN ANTIBACTERIAL AGENT IN COMPLICATED URINARY TRACT INFECTIONS

In this study, fleroxacin (FLRX), a new quinolone derivative, was orally given at 300mg once daily for 14 days to 102 patients with non-catheterized complicated urinary tract infections in order to determine the optimal treatment duration. We investigated its efficacy at day 5-7 and day 14, according to the criteria proposed by the Japanese UTI Committee, and also to the recurrence rate after the withdrawal.<BR>The results were as follows:<BR>1. Overall clinical efficacy rates were 86% at day 5-7 and 84% at day 14. Both incidence of bacterial replacement in bacteriuria and normalization in pyuria were increasedat day 14 as compared with those at day 5-7.<BR>2. Bacteriological eradication rates were 91% at day 5-7 and 89% at day 14.<BR>3. Clinical efficacy rates from physicians' evaluation were 86% at day 5-7 and 88% at day 14.<BR>4. Incidence of side effects was 9.1%, and most of the cases were gastrointestinal symptoms which appeared within 4 days. Slight and transitory changes in laboratory findingswere noted in 2.3% of evaluable cases.<BR>5. With the occurrence of pyuria and bacteriuria as markers, the “no recurrence” rates were 63% at 1 week, 54% at 2 weeks, 61% at 3 weeks, 81% at 4-6 weeks after the withdrawal, andthe “recurrence” rates were 4%, 4%, 6% and 5%, respectively. Remaining cases were judged as “reserved assessment”. Generally, aggravation of bacteriuria was found but the aggravation of pyuria was observed in only few cases.<BR>6. According to breakdown of cases with bacteriuria only, cure rate was 67% and recurrence rate was 33%. Re-infections were observed much more frequently than relapse based on the identification of infecting organisms.<BR>These results suggest that sufficient bacteriological eradication and clinical efficacy could be obtained by 14-day treatment of FLRX in non-catheterized complicated urinary tract infections. The efficacy of the treatment became evident around day 7. In approximately 30% of the cases in which eradication of the initial causative organisms was observed at day 14 reappearance of bacteriuria (≥10³CFU/ml) occurred after withdrawal of the antibiotic, but cases with pyuria were few, and the incidence of true recurrence was generally low. Onset of side effect after 5-day was not seen, hence FLRX seemed to be a safe agent.