In an open, randomized study, the effect of
pefloxacin (400 mg b.i.d.) was compared with that of
cefotaxime (1 g t.i.d.) in the treatment of complicated
urinary tract infections. In total 87 patients entered the study under the clinical diagnosis of complicated
urinary tract infection, of whom 49 were eligible for evaluation. Most isolates (90%) belonged to the family of Enterobacteriaceae. Isolates were eradicated from 96% (28/29) of patients treated with
pefloxacin and 89% (16/18) of those receiving
cefotaxime 48 h after the end of
therapy. After one week a total of 92% (22/24) of patients treated with
pefloxacin were culture negative, while in the group treated with
cefotaxime a total of 82% (9/11) were culture negative. After four to six weeks, 68% (13/19) in the
pefloxacin and 80% (8/10) in the
cefotaxime study group showed a negative urine culture (difference non-significant; p greater than 0.5). Clinical cure at the end of treatment was 97% (30/31) in the
pefloxacin group vs. 89% (16/18) in the
cefotaxime group. Both groups showed similar relapse and
reinfection rates at 48 h and one week after
therapy. Adverse effects were mild and reversible for both drugs. It is concluded that
pefloxacin is a safe and effective alternative for treatment of complicated
urinary tract infection.