Cefpodoxime vs Ciprofloxacin for Acute Cystitis

University of Washington

Status: Completed

Conditions: Urinary Tract Infection

Treatments: Drug: Ciprofloxacin; Drug: Cefpodoxime

Study type: Interventional

Funder types: Other

Identifiers

NCT00194532

27085-D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Cefpodoxime

Experimental group

Description:

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

Treatment:

Drug: Cefpodoxime

Ciprofloxacin

Active Comparator group

Description:

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

Treatment:

Drug: Ciprofloxacin