Cefpodoxime vs Ciprofloxacin for Acute Cystitis

NCT ID: NCT00194532

Last Updated: 2014-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2009-02-28

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.

Conditions

Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cefpodoxime

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

Group Type: EXPERIMENTAL

Cefpodoxime

Intervention Type: DRUG

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

Ciprofloxacin

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

Group Type: ACTIVE_COMPARATOR

Ciprofloxacin

Intervention Type: DRUG

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

Interventions

Cefpodoxime

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

Intervention Type: DRUG

Ciprofloxacin

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Ann Stapleton

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann Stapleton, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington, Department of Medicine

Locations

University of Miami Miller School of Medicine

Miami, Florida, United States

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22318279 (View on PubMed)

Other Identifiers

27085-D

Identifier Type: -

Identifier Source: org_study_id