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Cefpodoxime vs Ciprofloxacin for Acute Cystitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00194532
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : April 28, 2011
Last Update Posted : June 10, 2014
Information provided by (Responsible Party):
Ann Stapleton, 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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Drug: Cefpodoxime Drug: Ciprofloxacin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Cefpodoxime vs Ciprofloxacin for Acute Cystitis
Study Start Date : June 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cefpodoxime
Cefpodoxime 100mg twice a day(BID)for 3 days
Drug: Cefpodoxime
Cefpodoxime 100mg twice a day(BID)for 3 days

Active Comparator: Ciprofloxacin
Ciprofloxacin 250mg twice a day (BID)for 3 days
Drug: Ciprofloxacin
Ciprofloxacin 250mg twice a day (BID)for 3 days

Primary Outcome Measures :
  1. Clinical Cure [ Time Frame: 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 :
  1. Microbiologic Cure [ Time Frame: 1-15 days post therapy ]
    Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00194532

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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
Sponsors and Collaborators
University of Washington
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Principal Investigator: Ann Stapleton, MD University of Washington, Department of Medicine
Publications of Results:
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Responsible Party: Ann Stapleton, Professor, University of Washington Identifier: NCT00194532    
Other Study ID Numbers: 27085-D
First Posted: September 19, 2005    Key Record Dates
Results First Posted: April 28, 2011
Last Update Posted: June 10, 2014
Last Verified: June 2014
Keywords provided by Ann Stapleton, University of Washington:
Additional relevant MeSH terms:
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Urinary Tract Infections
Urologic Diseases
Urinary Bladder Diseases
Cefpodoxime proxetil
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors