title: Randomized, double-blind comparison of single-dose regimens of rufloxacin and pefloxacin for acute uncomplicated cystitis in women. French Multicenter Urinary Tract Infection-Rufloxacin Group.
abstract: In a double-blind, randomized, multicenter study, 463 adult women with symptomatic acute uncomplicated cystitis were treated orally with either a 400-mg single dose of rufloxacin (n = 226) or an 800-mg single dose of pefloxacin (n = 237). Escherichia coli (78%) and Proteus mirabilis (7%) were the most common isolates from 350 patients with significant pretreatment bacteriuria (uropathogens, > or = 10(5) CFU/ml). In the intention-to-treat analysis of patients with significant pretreatment bacteriuria, 343 patients were assessed for bacteriological outcome and 345 were assessed for clinical outcome. The bacteriological cure rate was 88% in the rufloxacin group and 84% in the pefloxacin group (95% confidence interval [CI] for difference in proportions, -4 to 12%), while the clinical resolution rate was 85 and 84%, respectively (95% CI, -8 to 9%). The per-protocol analysis demonstrated that among the 264 assessable patients, the bacteriological cure rate obtained with rufloxacin at 4 weeks of follow-up was comparable to that with pefloxacin (91 versus 85%; 95% CI, -3 to 15%). Among 295 clinically assessable patients, the clinical resolution rate at 4 weeks of follow-up was 89% in the rufloxacin group and 88% in the pefloxacin group (95% CI, -6 to 10%). Potentially drug-related adverse events occurred in 19% of the rufloxacin patients and in 18% of the pefloxacin patients. A single oral dose of 400 mg of rufloxacin is as effective and safe as a single oral dose of 800 mg of pefloxacin for the treatment of acute uncomplicated cystitis in women.
authors.affiliation: Service d'Urologie, Université Paris Sud, Centre Hospitalier Bicêtre, France.
authors.forename: A
authors.initials: A
authors.lastname: Jardin
authors.forename: M
authors.initials: M
authors.lastname: Cesana
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D003556:Cystitis / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D004926:Escherichia coli / Q000302:isolation & purification; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008875:Middle Aged; D015366:Pefloxacin / Q000627:therapeutic use*; D011513:Proteus mirabilis / Q000302:isolation & purification; D015363:Quinolones / Q000627:therapeutic use*
chemical_list: D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D015363:Quinolones; D015366:Pefloxacin; C060328:rufloxacin