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Antimicrobial Agents and Chemotherapy, October 2005, p. 4137-4143, Vol. 49, No. 10
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.10.4137-4143.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Efficacy and Safety of a Novel Once-Daily Extended-Release Ciprofloxacin Tablet Formulation for Treatment of Uncomplicated Urinary Tract Infection in Women

Jean L. Fourcroy,1 Bret Berner,2* Yu-Kun Chiang,2 Marilou Cramer,2 Lynne Rowe,2 and Neal Shore3

Uniformed Services University of the Health Sciences, Bethesda, Maryland,1 Depomed, Inc., Menlo Park, California,2 Grand Strand Urology, Myrtle Beach, South Carolina3

Received 6 April 2005/ Returned for modification 14 May 2005/ Accepted 14 July 2005

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 (≥105 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.

* Corresponding author. Mailing address: Depomed, Inc., 1360 O'Brien Drive, Menlo Park, CA 94025-1436. Phone: (650) 462-5900. Fax: (650) 462-9993. E-mail: bberner{at}depomedinc.com.

Antimicrobial Agents and Chemotherapy, October 2005, p. 4137-4143, Vol. 49, No. 10
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.10.4137-4143.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Leydon, G M, Turner, S, Smith, H, Little, P, on behalf of the UTIS team, (2010). Women's views about management and cause of urinary tract infection: qualitative interview study. BMJ 340: c279-c279 [Abstract] [Full Text]  
  • Washington, C., Hou, S. Y. E., Hughes, N. C., Campanella, C., Berner, B. (2007). Ciprofloxacin Prolonged-Release Tablets Do Not Affect Warfarin Pharmacokinetics and Pharmacodynamics. J Clin Pharmacol 47: 1320-1326 [Abstract] [Full Text]  
  • Washington, C., Hou, E., Hughes, N., Berner, B. (2006). Effect of omeprazole on bioavailability of an oral extended-release formulation of ciprofloxacin. Am J Health Syst Pharm 63: 653-656 [Abstract] [Full Text]  


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