NCT00194532

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

April 28, 2011

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

3.7 years

First QC Date

September 13, 2005

Results QC Date

March 30, 2011

Last Update Submit

June 3, 2014

Conditions

Urinary Tract Infection

Keywords

UTI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Microbiologic Cure

    1-15 days post therapy

Study Arms (2)

Cefpodoxime

EXPERIMENTAL

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

Drug: Cefpodoxime

Ciprofloxacin

ACTIVE COMPARATOR

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

Drug: Ciprofloxacin

Interventions

CefpodoximeDRUG

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

Cefpodoxime
CiprofloxacinDRUG

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

Ciprofloxacin

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Nonpregnant females in good general health with symptoms of acute cystitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related 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.

    PMID: 22318279RESULT

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

CefpodoximeCiprofloxacin

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFluoroquinolones4-QuinolonesQuinolonesQuinolines

Results Point of Contact

Title
Ann Stapleton, MD
Organization
University Of Washington
stapl@uw.edu
206-616-4121

Study Officials

  • Ann Stapleton, MD

    University of Washington, Department of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

June 1, 2005

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

June 10, 2014

Results First Posted

April 28, 2011

Record last verified: 2014-06

Locations

US(2)