Cefpodoxime vs Ciprofloxacin for Acute Cystitis - Full Text View

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 Drug: Ciprofloxacin

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Cefpodoxime vs Ciprofloxacin for Acute Cystitis

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Urinary Tract Infections

Drug Information available for: Cefpodoxime Ciprofloxacin Ciprofloxacin hydrochloride Cefpodoxime proxetil Ciprofloxacin lactate

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Clinical Cure [ Time Frame: 28-30 days post therapy ] [ Designated as safety issue: No ]
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 [ Time Frame: 1-15 days post therapy ] [ Designated as safety issue: No ]
Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up

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
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

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

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194532

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

Sponsors and Collaborators

University of Washington

Investigators

Principal Investigator:

Ann Stapleton, MD

University of Washington, Department of Medicine

More Information

No publications provided

Responsible Party:	Ann Stapleton, M.D., University of Washington
ClinicalTrials.gov Identifier:	NCT00194532 History of Changes
Other Study ID Numbers:	27085-D
Study First Received:	September 13, 2005
Results First Received:	March 30, 2011
Last Updated:	July 13, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

UTI

Additional relevant MeSH terms:

Cystitis
Urinary Tract Infections
Urinary Bladder Diseases
Urologic Diseases
Infection
Ciprofloxacin
Cefpodoxime
Cefpodoxime proxetil

Ceftizoxime
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 09, 2012