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| Sponsor: | University of Washington |
|---|---|
| Information provided by: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00194532 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Urinary Tract Infection |
Drug: Cefpodoxime vs Ciprofloxacin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Cefpodoxime vs Ciprofloxacin for Acute Cystitis |
| Estimated Enrollment: | 300 |
| Study Start Date: | June 2005 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Cefpodoxime
|
Drug: Cefpodoxime vs Ciprofloxacin
Cefpodoxime 100mg BID x 3 days Ciprofloxacin 250mg BID x 3 days
|
|
2: Active Comparator
Ciprofloxacin
|
Drug: Cefpodoxime vs Ciprofloxacin
Cefpodoxime 100mg BID x 3 days Ciprofloxacin 250mg BID x 3 days
|
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| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| University of Miami Miller School of Medicine | |
| Miami, Florida, United States, 33136 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | Ann Stapleton, MD | University of Washington, Department of Medicine |
More Information
| Responsible Party: | University of Washington ( Ann Stapleton, M.D. ) |
| Study ID Numbers: | 27085-D |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00194532 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
UTI |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Urinary Tract Infections Urinary Bladder Diseases Cystitis Enzyme Inhibitors Infection Cefpodoxime |
Pharmacologic Actions Anti-Bacterial Agents Ciprofloxacin Urologic Diseases Therapeutic Uses Cefpodoxime proxetil Nucleic Acid Synthesis Inhibitors |
