Cefpodoxime vs Ciprofloxacin for Acute Cystitis

Not Applicable

Completed

• Conditions: Urinary Tract Infection
• Interventions: Drug: Ciprofloxacin; Drug: Cefpodoxime

• Registration Number: NCT00194532
• Lead Sponsor: University of Washington

Brief 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.

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2011-03-30
• Results First Submitted QC: 2011-03-30
• Results First Posted: 2011-04-28
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciprofloxacin	Ciprofloxacin	Ciprofloxacin 250mg twice a day (BID)for 3 days
Cefpodoxime	Cefpodoxime	Cefpodoxime 100mg twice a day(BID)for 3 days

Primary Outcome Measures

Name	Time	Method
Clinical Cure	28-30 days post therapy	Participants with clinical cure, i.e. free of urinary tract symptoms and requiring no further antibiotic treatment, to assess the efficacy of a 3-day regimen of cefpodoxime compared to ciprofloxacin

Secondary Outcome Measures

Name	Time	Method
Microbiologic Cure	1-15 days post therapy	Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up

Trial Locations

Locations (2)

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

University of Washington; 🇺🇸 Seattle, Washington, United States