Skip to main content
OpenTrials
Completed

NCT Number: NCT00194532

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Miller School of Medicine, Miami, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefpodoxime

Drug

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

Ciprofloxacin

Drug

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

Primary outcomes

  1. Clinical Cure

    Time frame: 28-30 days post therapy

    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 outcomes

  1. Microbiologic Cure

    Time frame: 1-15 days post therapy

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Jun 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.