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Cefpodoxime vs Ciprofloxacin for Acute Cystitis

Primary Purpose

Urinary Tract Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cefpodoxime
Ciprofloxacin
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection focused on measuring UTI

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Miami Miller School of Medicine
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cefpodoxime

Ciprofloxacin

Arm Description

Cefpodoxime 100mg twice a day(BID)for 3 days

Ciprofloxacin 250mg twice a day (BID)for 3 days

Outcomes

Primary Outcome Measures

Clinical Cure
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

Microbiologic Cure
Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up

Full Information

First Posted
September 13, 2005
Last Updated
June 3, 2014
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00194532
Brief Title
Cefpodoxime vs Ciprofloxacin for Acute Cystitis
Official Title
Cefpodoxime vs Ciprofloxacin for Acute Cystitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
UTI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cefpodoxime
Arm Type
Experimental
Arm Description
Cefpodoxime 100mg twice a day(BID)for 3 days
Arm Title
Ciprofloxacin
Arm Type
Active Comparator
Arm Description
Ciprofloxacin 250mg twice a day (BID)for 3 days
Intervention Type
Drug
Intervention Name(s)
Cefpodoxime
Intervention Description
Cefpodoxime 100mg twice a day(BID)for 3 days
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
Ciprofloxacin 250mg twice a day (BID)for 3 days
Primary Outcome Measure Information:
Title
Clinical Cure
Description
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
Time Frame
28-30 days post therapy
Secondary Outcome Measure Information:
Title
Microbiologic Cure
Description
Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up
Time Frame
1-15 days post therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Stapleton, MD
Organizational Affiliation
University of Washington, Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22318279
Citation
Hooton TM, Roberts PL, Stapleton AE. Cefpodoxime vs ciprofloxacin for short-course treatment of acute uncomplicated cystitis: a randomized trial. JAMA. 2012 Feb 8;307(6):583-9. doi: 10.1001/jama.2012.80.
Results Reference
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Cefpodoxime vs Ciprofloxacin for Acute Cystitis

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