Cefpodoxime vs Ciprofloxacin for Acute Cystitis
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Tract Infection
Intervention: Cefpodoxime (Drug); Ciprofloxacin (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Washington Official(s) and/or principal investigator(s): Ann Stapleton, MD, Principal Investigator, Affiliation: University of Washington, Department of Medicine
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Clinical Cure
Secondary outcome: Microbiologic Cure
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
University of Miami Miller School of Medicine, Miami, Florida 33136, United States
University of Washington, Seattle, Washington 98195, United States
Additional Information
Starting date: June 2005
Last updated: June 3, 2014
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