ANTIBIOPROPHYLAXIS OF RECURRENT CYSTITIS - A RANDOMIZED DOUBLE-BLIND TRIAL WITH 2 PEFLOXACIN REGIMENS

Objectives : The aim of this randomized double-blind trial was to comp are two 400 mg pefloxacin regimens either once-a-week or once-a-month applied for 48 weeks for the prophylaxis of recurrent urinary tract in fection in women. Methods : The main outcome measures were symptomatic and bacteriological reinfections during the period of prolphylaxis an d rates of reinfections during the three months of surveillance follow ing the end of prophylaxis. 361 women of 18 to 51 years of age sufferi ng from recurrent lower urinary tract infection were randomly allocate d to receive pefloxacin 400 mg once-a-week (group A: n = 185) or 400 m g once-a-month (groupe B: n = 176) for 48 weeks. Results : Seventeen o f 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 proph ylaxis (p < 0.0001). The rates of reinfection during the three months of surveillance following the end of the treatment were not significan tly 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 ca n be considered as a new effective and well tolerated approach for the prophylaxis of recurrent urinary tract infection in women and does no t entail excessive emergence of pefloxacin resistant bacteria, even af ter 48 weeks of treatment.