Cefpodoxime vs Ciprofloxacin for Acute Cystitis

Urinary Tract Infection Clinical Trial

Official title:

Cefpodoxime vs Ciprofloxacin for Acute Cystitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194532
• Other study ID #: 27085-D
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: June 3, 2014
• Start date: June 2005
• Est. completion date: February 2009

Study information

• Verified date: June 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Cefpodoxime
Cefpodoxime 100mg twice a day(BID)for 3 days
• Ciprofloxacin
Ciprofloxacin 250mg twice a day (BID)for 3 days

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Microbiologic Cure	Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up	1-15 days post therapy	No