Cefpodoxime vs Ciprofloxacin for Acute Cystitis

This study has been completed.

Study NCT00194532 Information provided by University of Washington

First Received on September 13, 2005. Last Updated on July 13, 2011 History of Changes

Results First Received: March 30, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver); Primary Purpose: Treatment
Condition:	Urinary Tract Infection
Interventions:	Drug: Cefpodoxime Drug: Ciprofloxacin

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Ciprofloxacin	Ciprofloxacin 250 mg BID X 3 days
Cefpodoxime	Cefpodoxime 100 mg BID X 3 days

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Ciprofloxacin	Ciprofloxacin 250 mg BID X 3 days
Cefpodoxime	Cefpodoxime 100 mg BID X 3 days

Baseline Measures

	Ciprofloxacin	Cefpodoxime	Total
Number of Participants [units: participants]	150	150	300
Age [units: years] Mean ( Full Range )	24 ( 18 to 55 )	23 ( 17 to 44 )	24 ( 17 to 55 )
Gender [units: participants]
Female	150	150	300
Male	0	0	0
Region of Enrollment [units: participants]
United States	150	150	300

Outcome Measures

1. Primary:

Clinical Cure [ Time Frame: 28-30 days post therapy ]

Show Outcome Measure 1

2. Secondary:

Microbiologic Cure [ Time Frame: 1-15 days post therapy ]

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Ann Stapleton, MD
Organization: University Of Washington
phone: 206-616-4121
e-mail: stapl@uw.edu

No publications provided by University of Washington

Publications automatically indexed to this study:

Responsible Party:	Ann Stapleton, M.D., University of Washington
ClinicalTrials.gov Identifier:	NCT00194532 History of Changes
Other Study ID Numbers:	27085-D
Study First Received:	September 13, 2005
Results First Received:	March 30, 2011
Last Updated:	July 13, 2011
Health Authority:	United States: Institutional Review Board