[Antibioprevention of recurrent cystitis. A randomized double-blind comparative trial of 2 dosages of pefloxacin]

Abstract

Objectives: The aim of this randomized double-blind trial was to compare two 400 mg pefloxacin regimens either once-a-week or once-a-month applied for 48 weeks for the prophylaxis of recurrent urinary tract infection in women.

Methods: The main outcome measures were symptomatic and bacteriological reinfections during the period of prophylaxis and rates of reinfections during the three months of surveillance following the end of prophylaxis. 361 women of 18 to 51 years of age suffering from recurrent lower urinary tract infection were randomly allocated to receive pefloxacin 400 mg once-a-week (group A: n = 185) or 400 mg once-a-month (groupe B: n = 176) for 48 weeks.

Results: Seventeen of the 185 patients in group A (9.1%) and 52/176 patients in group B (29.5%) experienced at least one reinfection during the period of prophylaxis (p < 0.0001). The rates of reinfection during the three months of surveillance following the end of the treatment were not significantly different between the two groups with 14/101 (13.8%) patients with at least a reinfection in group A and 8/75 patients (10.6%) in group B (p = 0.51). In group A, 49/174 (28.1%) patients reported at least an adverse event compared with 33/169 (19.5%) patients in group B (p = 0.06).

Conclusions: Once-a-week treatment with 400 mg of pefloxacin can be considered as a new effective and well tolerated approach for the prophylaxis of recurrent urinary tract infection in women and does not entail excessive emergence of pefloxacin resistant bacteria, even after 48 weeks of treatment.