To evaluate the efficacy of the oral cephem antibiotic cefcapene pivoxil (CFPN-PI) against complicated noncatheterized urinary-tract infections, we conducted a comparative study by the envelope method using the quinolone antibiotic levofloxacin (LVFX), as the comparative drug.Both drugs were administered at 100 mg per dose 3 times a day for 7 days.Clinical efficacy was evaluated based on the UTI Drug Efficacy Evaluation Standards (4
th edition).No significant difference in background factors was seen between groups.
In early-phase evaluation, overall clinical efficacy was 84.4% among 32 cases in the CFPN-PI administration group and 86.1% among 36 cases in the LVFX administration group.
When late-phase microbiological outcome was evaluated 1 week after the completion of administration, 66.7% was judged “eradicated” and 33.3% “failed” among 27 cases in the CFPN-PI group and 81.5% “eradicated” and 24.1% were judged “eradication” and “failed” among 29 cases in the LVFX group.
When the microbiological outcome was evaluated for healing at 1 month after the completion of administration, 76.4% was judged “eradicated” and 23.1% “failed” among 13 cases in the CFPN-PI group and 58.3% “eradicated” and 41.7% “failed” among 12 cases in the LVFX group.No significant difference was seen between groups in any evaluations.
Side effects were observed in 1 of 77 cases (1.3%) in the CFPN-PI group and in 3 of 75 cases (4.0%) in the LVFX administration group, with no significant difference between groups.
CFPN-PI thus showed effects similar to LVFX and was found to be useful against bacterial strains adopted in complicated noncatherized urinary-tract infection when treatment outcomes for healing at 1 month was evaluated as the endpoint using UTI Drug Efficacy Standards (4
th Edition).
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