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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

Page last updated: August 23, 2015

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