Cefpodoxime vs Ciprofloxacin for Acute Cystitis

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infection
• Intervention / Treatment: Drug: Cefpodoxime; Drug: Ciprofloxacin

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28-30 days post therapy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Ann Stapleton, MD, University of Washington, Department of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): June 10, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: UTI
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Bladder Diseases; Cystitis; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin; Cefpodoxime; Cefpodoxime proxetil
• Other Study ID Numbers: 27085-D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No