title: Efficacy and safety of a novel once-daily extended-release ciprofloxacin tablet formulation for treatment of uncomplicated urinary tract infection in women.
abstract: The efficacy and safety of a novel once-daily extended-release ciprofloxacin (ciprofloxacin ER) 500-mg dose were compared with those of an immediate-release ciprofloxacin (ciprofloxacin IR) 250-mg twice-daily dose, each administered orally for 3 days in the treatment of acute uncomplicated urinary tract infection (uUTI) in women. Adult female outpatients (mean age, 39 years) with clinical signs and symptoms of acute uUTI and a positive pretreatment urine culture (> or =10(5) CFU/ml) were enrolled in a multicenter, randomized, double-blind, noninferiority trial. Patients were assessed at a test-of-cure visit (4 to 11 days posttreatment) and a late-posttreatment visit (4 to 6 weeks posttreatment) for microbiological and clinical outcomes and safety. The primary efficacy endpoint and microbiological eradication rate at the test-of-cure visit in the ciprofloxacin ER group (254/272; 93.4%) were noninferior to those in the ciprofloxacin IR group (225/251; 89.6%) (95% confidence interval [CI] of difference, -0.99%, 8.59%). Clinical-cure rates at the test-of-cure visit were 85.7% (233/272) for ciprofloxacin ER and 86.1% (216/251) for ciprofloxacin IR (95% CI of difference, -6.37%, 5.57%). At the late-posttreatment visit, microbiological and clinical outcomes were similar for the two treatments and consistent with test-of-cure results. Both treatments were well tolerated, but the frequencies of nausea and diarrhea were lower in the ciprofloxacin ER group than in the ciprofloxacin IR group (nausea, ER, 0.6%; IR, 2.2%; P = 0.033; diarrhea, ER, 0.2%; IR, 1.4%; P = 0.037). Once-daily ciprofloxacin ER was safe, effective, and noninferior to twice-daily ciprofloxacin IR in the treatment of acute uUTI. Additionally, ciprofloxacin ER was associated with significantly reduced frequencies of nausea and diarrhea.
authors.affiliation: Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
authors.forename: Jean L
authors.initials: JL
authors.lastname: Fourcroy
authors.forename: Bret
authors.initials: B
authors.lastname: Berner
authors.forename: Yu-Kun
authors.initials: YK
authors.lastname: Chiang
authors.forename: Marilou
authors.initials: M
authors.lastname: Cramer
authors.forename: Lynne
authors.initials: L
authors.lastname: Rowe
authors.forename: Neal
authors.initials: N
authors.lastname: Shore
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000892:Anti-Infective Agents, Urinary / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D003967:Diarrhea / Q000188:drug therapy; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009325:Nausea / Q000188:drug therapy; D010045:Outpatients; D013607:Tablets; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000188:drug therapy* / Q000382:microbiology
chemical_list: D000892:Anti-Infective Agents, Urinary; D003692:Delayed-Action Preparations; D013607:Tablets; D002939:Ciprofloxacin