INTERPRETATION OF THE BACTERIOLOGICAL OUTCOME OF ANTIBIOTIC-TREATMENTFOR UNCOMPLICATED CYSTITIS - IMPACT OF THE DEFINITION OF SIGNIFICANT BACTERIURIA IN A COMPARISON OF RITIPENEM ACOXIL WITH NORFLOXACIN

The efficacy and safety of a 5-day course of treatment with the new or al penem agent ritipenem acoxil (500 mg three times daily) or with nor floxacin (200 mg twice daily) were assessed in a double-blind study of women with uncomplicated cystitis. The effects of the definition of b acteriuria used on the interpretation of treatment outcome were also a nalyzed. Of 281 women randomized to one of the two treatment arms, 84% were evaluable in terms of the bacteriologic efficacy of therapy; 99% of the evaluable patients returned for the first follow-up examinatio n and 92% for the second. Five to 9 days after the completion of thera py, persistent bacteriuria was documented in more women given ritipene m acoxil than norfloxacin (95% confidence interval, 0.14; 0.38). The t wo groups did not differ markedly with regard to bacteriologic or clin ical outcome 3 to 4 weeks after treatment. Subanalyses of bacteriologi c outcome showed that failure rates varied between 6% and 67% for riti penem acoxil and between 1% and 43% for norfloxacin, depending on how significant posttherapy bacteriuria was defined; systematic studies ar e clearly needed on how best to define significant posttherapy bacteri uria. Ritipenem acoxil caused significantly more adverse reactions (es pecially diarrhea or loose stools) than norfloxacin (P < .005).