Cefpodoxime vs Ciprofloxacin for Acute Cystitis
Information source: University of Washington
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Tract Infection
Intervention: Cefpodoxime vs Ciprofloxacin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Washington Official(s) and/or principal investigator(s):
Ann Stapleton, MD, Principal Investigator, Affiliation: University of Washington, Department of Medicine
Overall contact:
Niki A DeShaw, Phone: 206-685-1048, Email: ndeshaw@u.washington.edu
Summary
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.
Clinical Details
Official title: Cefpodoxime vs Ciprofloxacin for Acute Cystitis
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: To assess the efficacy of a 3-day regimen of cefpodoxime
Secondary outcome: To assess the tolerance of a 3-day regimen of cefpodoxime
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Niki A DeShaw, Phone: 206-685-1048, Email: ndeshaw@u.washington.edu
University of Miami Miller School of Medicine, Miami, Florida 33136, United States; Recruiting
Thomas M Hooton, MD, Phone: 305-243-2576, Email: THooton@med.miami.edu
Thomas M Hooton, MD, Principal Investigator
University of Washington, Seattle, Washington 98195, United States; Recruiting
Ann Stapleton, MD, Phone: 206-616-4121, Email: stapl@u.washington.edu
Ann Stapleton, MD, Principal Investigator
Additional Information
Starting date: June 2005
Ending date: June 2009
Last updated: August 19, 2008
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