Official Title: “Cefpodoxime vs Ciprofloxacin for Acute Cystitis”

Urinary tract infection (UTI) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20s. One of the most common antibiotics used to treat UTIs is ciprofloxacin, usually for a total of three days. However, increasing resistance to this antibiotic has raised concerns about its overuse for cystitis and generated interest in alternative agents. An alternative antibiotic which is approved for use in UTIs is cefpodoxime. However, there are few studies evaluating the efficacy and tolerance of this compound when given in a 3-day regimen as is commonly used for treatment of UTI. The major purpose of this study is to assess the efficacy and tolerance of a 3-day regimen of cefpodoxime versus ciprofloxacin for treatment of acute uncomplicated cystitis.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

Procedures subjects will undergo once they have read and signed the consent are:

Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine and peri-urethral sample and then are randomly assigned to one of the two treatment groups.They will be given a sheet to record symptoms at home. They will be asked to return to the clinic in 5-9 and 28-30 days after completing antibiotic therapy.Follow-up questions will be asked and urine and peri-urethral will be self collected at each visit.

Intervention(s) in this Clinical Trial

• Drug: Cefpodoxime vs Ciprofloxacin
  • Cefpodoxime 100mg BID x 3 days Ciprofloxacin 250mg BID x 3 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Cefpodoxime
• Active Comparator: 2
  • Ciprofloxacin

Primary Measures

• To assess the efficacy of a 3-day regimen of cefpodoxime
  • Time Frame: 28-30 days post therapy
    Safety Issue?: No

Secondary Measures

• To assess the tolerance of a 3-day regimen of cefpodoxime
  • Time Frame: 28-30 days post therapy
    Safety Issue?: No

Inclusion Criteria:

• Nonpregnant females in good general health with symptoms of acute cystitis

Exclusion Criteria:

• Pregnant,lactating, or not regularly contracepting: known anatomic abnormalities of the urinary tract; use of prophylactic antibiotics; history of allergy or intolerance to any of the study drugs; recent (>2 weeks)exposure to an oral or parenteral antimicrobial; or history of UTI in the previous 1 month

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Washington

Overall Clinical Trial Officials and Contacts

Ann Stapleton, MD Principal Investigator University of Washington, Department of Medicine  

Overall Contact: Niki A DeShaw 206-685-1048 ndeshaw@u.washington.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00194532

Study ID Number: 04-4351-D 01

ClinicalTrials.gov Identifier: NCT00194532

Health Authority: United States: Institutional Review Board